Why Choose Us?
Trust
Trust is one of our most important values. That's why we place great importance on the security of your data and only exchange it with you via secure servers in Germany.
Customer Satisfaction
Your satisfaction is our highest goal in all projects. For us, a project is only successful if you are satisfied!
Reliability
Do you need to solve a critical problem at short notice? Together, we can do it – even with an overnight shift if necessary. Because we are always there for our customers.
Four reasons to choose us for clinical evaluation
- You benefit from our many years of experience in the field of clinical evaluations.
- Your clinical evaluation is prepared quickly and reliably by us.
- With us as your professional partner, you will navigate conformity assessment procedures smoothly!
- Your satisfaction is our top priority.
Our experts prepare the Clinical Evaluation Plan (CEP) as well as the Clinical Evaluation Report (CER) for medical devices of classes I to III.
With thinqbetter, you have a partner who prepares your evaluation quickly, efficiently, and reliably as an external service provider.
Clinical evaluations: our services
Our experts support you in every aspect of preparing and updating clinical evaluations — for medical devices in classes I, IIa, IIb, and III, as well as for software.
Our evaluations comply with the requirements of the MDR, as regularly confirmed by notified bodies.
We update your clinical evaluation – in full or in part, tailored precisely to your needs.
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Principle of clinical evaluation according to the MDR
For all medical devices regulated by the Medical Device Regulation (MDR), evidence of safety, performance, and clinical benefit must be demonstrated. This requirement is fulfilled through the clinical evaluation of medical devices.
By definition of the MDR, the following applies: A clinical evaluation […] “is a systematic and planned process for the continuous generation, collection, analysis, and assessment of clinical data relating to a product, in order to verify the safety and performance, including the clinical benefit, of the product when used as intended by the manufacturer [MDR].” In essence, the aim is to demonstrate that a medical device performs in line with its intended purpose.
The clinical evaluation under the MDR essentially comprises two components: (1) a plan that, among other aspects, defines the preparation and updating of the clinical evaluation, and (2) a report that documents the activities performed – such as the collection and analysis of clinical data – along with the resulting conclusions.
Clinical evaluations: stages according to MEDDEV
MEDDEV 2.7/1 Revision 4 had already established a meaningful and proven structure under Directive 93/42/EEC (MDD). This framework should continue to serve as a reference under the MDR – after all, there is no need to reinvent the wheel.
When applied at the document level, Stage 0 is documented in the plan (CEP), as the name implies. The subsequent stages describe the activities performed and are recorded in the report (CER).
Collecting, evaluating, and analyzing data is a key component of literature review and analysis. Further details can be found in the section “Literature and Clinical Data” further down on this page.
If you have any questions or would like to book a service, please feel free to contact us!
Further down the page, you will find an overview of relevant content. There you will find general information on the topic.
Clinical Evaluation Plan (CEP)
The preparation of a clinical evaluation must be planned, as explicitly required by the MDR. The specific contents of the plan are outlined in Annex XIV, Part A, point 1, and include, among others, the following aspects:
- Definition of the essential safety and performance requirements that must be supported by relevant clinical data,
- Defining the intended purpose of the product,
- precise specification of the intended target groups with clear indications and contraindications,
- Detailed description of the intended clinical benefit for patients with relevant specific parameters for the clinical outcome.
- clinical development plan,
- and a few other requirements.
It quickly becomes clear that even planning a clinical evaluation is quite extensive. However, the detailed requirements also have a positive aspect: the content to be provided is clearly addressed. MEDDEV 2.7-1 Revision 4 also provides helpful guidance on many points. Although this refers to 93/42/EEC (MDD), the basic concept has not been reinvented by the MDR.
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Clinical Evaluation Report (CER)
The CER documents the activities performed as planned in the CEP. It applies the clearly defined and methodologically sound procedure required under Article 61 of the MDR. The outcome is a comprehensive report demonstrating the safety, performance, and clinical benefit of the medical device.
The report brings together data and insights from preclinical areas such as risk management, usability, and biocompatibility, as well as from clinical areas including literature review, analysis, and post-market surveillance. Based on this solid foundation, the medical device is assessed for safety and performance. Furthermore, the report demonstrates the clinical benefit, which is essential to substantiate clinical evidence.
The sheer amount of diverse data highlights the complexity of clinical evaluation of medical devices. The author must be capable of evaluating this data in the proper context and at the appropriate content level to derive accurate and meaningful conclusions.
Basis of the clinical evaluation: Clinical data
As the term suggests, clinical evaluation is based on clinical data. According to the MDR, such data comprise “information on safety or performance obtained from the use of a product.” The following sources of clinical data can be distinguished:
- “clinical investigation(s) of the respective product”
- clinical investigation(s) or other studies reported in scientific literature, of a device for which equivalence to the device in question can be demonstrated,
- reports published in peer reviewed scientific literature on other clinical experience of either the device in question or a device for which equivalence to the device in question can be demonstrated,
- clinically relevant information from post-market surveillance, in particular from post-market clinical follow-up [MDR].”
A common way to identify such data is through a literature review, in which published studies are systematically identified and used as a data source. The following section outlines how such a literature review is performed.
Central element of the clinical evaluation: literature review
The literature review is a key element of clinical evaluation, particularly when no clinical investigation has been conducted with your product.
- Step 1: Analyze the intended purpose and clinical claims, including patient population, indications, and contraindications. Data relating to these aspects are then identified through the literature review.
- Step 2: Identify data sources that provide clinical data, such as PubMed, Cochrane, and Embase.
- Step 3: Define search terms and objective filters to capture data on the medical device under evaluation, on comparator products, and on the state of the art.
- Step 4: Identified literature is initially screened at the abstract level and assessed for potential relevance.
- Step 5: Potentially relevant literature is then subjected to an in-depth analysis at the full-text level.
- Step 6: The clinical data derived from the full-text analyses are then used to substantiate the clinical evidence.
Various databases may be used to conduct the literature review. A minimum of two should be included:
- PubMed
- Cochrane
- Embase
- ScienceDirect
- Google scholar
- etc.
When documenting the literature review for the clinical evaluation, it is essential to ensure full reproducibility. A third party (e.g., auditor, notified body, or competent authority) must be able to find sufficient information in your documentation to replicate the search and obtain the same results as your original process.
Regarding PubMed, it must be said that the indexing of publications is changed from time to time. This means that with the same search protocol, a fully reproducible search is not always possible if some time has passed in between. This is now known to many people, but unfortunately not to everyone. Nevertheless, PubMed remains a popular database for literature searches because it is comprehensive and easy to use.
The use of different databases, but also different search terms within a database, usually leads to duplicates. For the clinical evaluation, each publication may only be used once. Therefore, check your results for duplicates!
Lack of clinical data for a clinical evaluation
What if, during the preparation of the CER, it becomes apparent that there are insufficient clinical data for your medical device?
Is it possible to develop a clinical evaluation without clinical data?
“If demonstration of conformity with the general safety and performance requirements based on clinical data is deemed inappropriate, this exception must be properly justified on the basis of the manufacturer’s risk management, while considering the specific characteristics of the interaction between the product and the human body, the intended clinical performance, and the manufacturer’s claims […]. In such cases, the manufacturer must provide due justification in the technical documentation […] as to why demonstrating conformity with the general safety and performance requirements solely on the basis of non-clinical testing methods – including performance evaluation, bench testing, and pre-clinical evaluation – is considered sufficient [MDR].”
Fortunately for patients, approval without sufficient data is not possible. The principle relies on an adequate body of data, without which compliance with the general safety and performance requirements cannot be demonstrated.
Approval without clinical data is possible only in very few exceptional cases. What we frequently observe with clients, however, is that insufficient clinical data are identified during the clinical evaluation, resulting in challenges in the approval process.
The ideal solution to this problem is to adjust the literature review for the clinical evaluation. In many cases, issues arise from an unfavorable combination of search terms, filters, or comparator products. While the suitability of the search protocol should in principle be verified during its development, this can sometimes prove challenging or may simply be overlooked.
If such adjustments still prove insufficient, clinical studies or investigations must be carried out to generate the necessary data. For manufacturers holding valid MDD certificates, it is advisable to use the validity period of these certificates to assess whether sufficient data are available to meet the MDR requirements for clinical evaluation.
The use of data from equivalent products has become significantly more challenging under the MDR compared to the MDD. For this reason, it is advisable to begin generating sufficient clinical data already during the MDD period, in order to avoid being compelled to conduct a clinical investigation with a non-approved product. The associated requirements for ethics committee approval, along with the considerable financial and time burden, are substantial and should be avoided whenever possible.
Organizational project preparation
Software tools:
We use software to keep track of our projects. Therefore, the first step is to set up a new project.
Software tools:
We use software to track project work with second-level precision. The first step is to set up a new project in the time tracking system.
Quality management:
Within the scope of our quality management system, competent personnel are assigned to your project.
Operational project preparation
Project management:
Detailed planning of the required project deliverables
Project risk management:
Analysis of potential project risks with defined mitigation measures
Customer communication:
Definition of suitable communication channels and designated contacts
Quality management:
Acquisition of the necessary input information and documents
Project execution
Quality management:
Internal project kick-off meeting
Quality management:
Execution of the project in defined work packages
Quality management:
The outcomes of the work packages are subject to internal quality control procedures
External review
Customer communication:
Client review of the project deliverables
Quality management:
Improvement of the project results, if required
Service release
Quality management:
Approval of the final project deliverables
Customer communication:
Delivery of the final project deliverables to our client
Project completion
Quality management:
Archiving of the project deliverables
GDPR:
Deletion of input documents and information
Software tools:
Archiving the project in our project management system
Software tools:
Archiving the project in our time tracking system
Clinical evaluation: interfaces
Interface with risk management
During the analysis of identified data, risks may emerge in relation to the medical device or comparator product that had not previously been considered in risk management. Consequently, after data analysis, a reconciliation is performed between the risks identified in the CER and those in the existing risk analysis.
If new risks are identified, they must be integrated into the risk management (RM) process to ensure proper analysis.
Interface with usability
Interface with post-market surveillance (PMS)
Interface with post-market clinical follow-up (PMCF)
The clinical evaluation is closely connected with your PMCF activities. PMCF generates clinical data on your product that feed directly into the clinical evaluation.
PMCF can be valuable even under the MDD to generate sufficient clinical data for MDR approval of your product. Contact us to learn how PMCF can simplify your path and make the process easier for you.
Manufacturers with portfolios consisting solely of Class I medical devices often ask us: “Do we actually need a clinical evaluation for a Class I medical device? Under the MDD, this was not required.”
The MDD was transposed into national law through the German Medical Devices Act (MPG). Section 19 “Clinical Evaluation” stated: “The suitability of medical devices for their intended purpose must be demonstrated by a clinical evaluation based on clinical data pursuant to Section 3, No. 25, unless, in justified exceptional cases, other data are deemed sufficient. The clinical evaluation must include an assessment of adverse effects as well as the acceptability of the benefit-risk ratio referred to in the Essential Requirements of Directives 90/385/EEC and 93/42/EEC. It must be carried out using a defined and methodologically sound procedure, taking into account relevant harmonized standards, where appropriate.”
This provision was never intended as a loophole to bypass clinical evaluation. It did, however, permit the use of non-clinical data in justified exceptional cases.
The same applies under the MDR (EU 2017/745). Article 61(10) likewise provides a narrow exception allowing clinical evaluation without clinical data — but only in justified exceptional cases.
The answer to this question is clear: “Yes, a clinical evaluation is required for every medical device.”
Clinical evaluation for software (SaMD)
The clinical evaluation of software medical devices, such as smartphone apps, differs from that of traditional medical devices. This is both logical and appropriate, as the interaction between software and the patient is fundamentally different from the interaction between a traditional medical device and a patient.
Software delivers information that may, in turn, cause harm. However, software itself cannot directly cause physical harm to individuals — it does not physically interact with the patient.
The different processes of clinical evaluation for software are outlined in MDCG 2020-1. Below, we provide its table of contents as an example to give you an initial overview.
MDCG 2020-1 essentially describes three aspects:
- valid clinical association
- technical Performance
- clinical Performance
The concept of “valid clinical association” closely parallels the principle of scientific validity for IVDs in the context of performance evaluation. In simple terms, it requires evidence that the information provided by the software is linked to a clinical or physiological condition.
For an IVD, this is easier to illustrate. Take the example of a COVID-19 rapid test: the test is intended to detect a COVID-19 infection. To do so, evidence of scientific validity is required to show that the parameter measured by the rapid test is actually associated with a COVID-19 infection. Without such an association, the test result cannot demonstrate the presence of a COVID-19 infection — regardless of the product’s performance. In such a case, it is simply impossible to establish this type of evidence.
The same type of evidence must therefore be provided for software as a medical device. Does the information it delivers correspond to the clinical or physiological condition defined in the intended purpose?
“Technical performance” refers to the ability of software to generate the intended technical output accurately and reliably based on the input data.
At this stage, it must be demonstrated at the technical level that the software produces correct outputs from the given inputs. Such evidence is typically generated during software development, as the software algorithms are verified and optimized.
What remains, therefore, is the demonstration of clinical performance. As with traditional medical devices, this requires data demonstrating that the software has been tested for its intended use(s), target population(s), conditions of use, operating and usage environments, and across all intended user groups.
The exact approach to demonstrating clinical performance must be determined on a case-by-case basis. It is important to note that Article 61(10) of the MDR also applies in this context — providing a pathway for cases where demonstration of conformity based on clinical data is not appropriate.
The role of clinical investigations and GCP in clinical evaluation
For many legacy products, and particularly for new developments, conducting clinical investigations or PMCF studies is the necessary route to generate the clinical data required for regulatory approval. Given the extensive requirements under GCP (Good Clinical Practice, ISO 14155, and applicable legal frameworks) for the conduct of clinical investigations, this process is associated with a significant documentation burden.
Some of our clients have in-house staff focused solely on study planning and coordination. Others place their trust in our study partner, who provides a convenient and cost-efficient turnkey solution.
For more insights on GCP and the MDR, we recommend reading our blog post. Should you have any questions on the topic, we would be delighted to hear from you!
Clinical evaluation as part of the technical documentation
Conformity assessment
Annex IX:
Conformity assessment based on a quality management system and review of the technical documentation – As the name implies, this route requires comprehensive technical documentation for your product.*
Annex X:
Conformity assessment based on type examination – “EU type examination is the procedure by which a Notified Body ascertains and certifies that a product, including the technical documentation and the relevant processes throughout the lifecycle, as well as a representative sample of the medical device intended for production, comply with the relevant provisions of this Regulation [MDR].”
Annex XI:
Conformity assessment based on product conformity verification – This procedure presupposes successful completion of the Annex X procedure and likewise requires technical documentation.
Conclusion:
Without a clinical evaluation, the technical documentation pursuant to Annex II is incomplete. As a result, the medical device cannot be approved, as all conformity assessment procedures require complete technical documentation.
Consideration of the MDCG documents for clinical evaluation
While the legal requirements for clinical evaluation stem exclusively from the MDR, Notified Bodies nevertheless expect MDCG guidance documents to be duly considered. Moreover, these documents are highly useful for developing a clearer understanding of expectations. Thorough preparation is worthwhile, as any deviations identified by the Notified Body will be followed up and may lead to additional costs.
| Document | short description |
|---|---|
| MEDDEV 2.7/1 Rev. 4 | Although the document was originally developed under 93/42/EEC (MDD), it continues to provide important guidance on the process of clinical evaluation. MDCG 2020-6 specifies which sections of the MEDDEV remain applicable. However, even the sections no longer applicable may still provide valuable insights. |
| MDCG 2020-1 | Software as a medical device also requires clinical evaluation. However, the process differs somewhat from that of other products. MDCG 2020-1 offers useful guidance in this regard. |
| MDCG 2020-5 | The equivalence route for clinical evaluation, widely used under the MDD, is no longer available. Under the MDR, it is now limited to only a few products. Further details will follow later. |
| MDCG 2020-6 | Legacy products — so-called legacy devices — can be transitioned to the MDR more smoothly than entirely new approvals. This document is highly recommended reading! |
| MDCG 2020-13 | The Clinical Evaluation Assessment Report outlines what a Notified Body examines when reviewing the clinical evaluation. Knowing this enables you to prepare more effectively. |
| MDCG 2024-10 | Orphan medical devices — products intended for very small patient populations — are specifically covered in MDCG 2024-10. |
MDCG 2020-05 – Equivalence for clinical evaluation
Using data from equivalent products can be a practical way to gather sufficient clinical evidence to demonstrate compliance with the applicable Essential Safety and Performance Requirements. Under 93/42/EEC (MDD), it was more broadly permitted to rely on data from sources other than the manufacturer’s own product. The MDR, however, has made this significantly more difficult, meaning that even established products may face challenges in terms of data availability.
In April 2020, the Medical Device Coordination Group (MDCG) issued a document outlining guidance on equivalence for both Notified Bodies and manufacturers.
The document is specifically intended to highlight the differences between MEDDEV 2.7-1 Revision 4 and the MDR requirements.
Even under MEDDEV, equivalence was linked to the aspects of technical, biological, and clinical characteristics of the products. These characteristics are meaningful points of comparison and remain in place under the MDR.
With respect to biological characteristics, the MDR stipulates: “The device shall use the same materials or substances in contact with the same human tissues or body fluids, for a similar type and duration of contact, and with similar release characteristics of substances, including degradation products and leachables.” Under MEDDEV, material deviations were still permissible, for example in products with contact to intact skin. In some cases, a risk assessment could justify components with different materials being considered equivalent. The new requirement that both the duration and type of contact must be similar further illustrates that the MDR is considerably more stringent regarding biological characteristics.
Clinical characteristics: Under the MDR, products must now be intended for use by the same category of users — for instance, healthcare professionals or laypersons.
Technical characteristics: Under the MDR, products must be used under comparable conditions of use, whereas MEDDEV required them to be identical. In addition, the MDR stipulates that, for software, the algorithms of the compared products must be similar.
Overall, it is evident that the MDR makes reliance on equivalent products from other manufacturers extremely challenging. This underscores the importance of generating sufficient post-market surveillance data, which can still be collected during the validity period of MDD certificates and leveraged as part of the regulatory basis for MDR approval.
If equivalence cannot be demonstrated, it may still be possible to draw on data from similar products. In many cases, products that are “no longer equivalent” can serve this purpose effectively.
Such data may be utilized for the following purposes:
- Ensure the risk management system is comprehensive through the identification of relevant hazards and clinical risks.
- Understanding the state of the art, the natural progression of the disease, and alternative treatment options available.
- Supporting the definition of the clinical evaluation scope by identifying design characteristics of similar products that may raise specific performance or safety concerns.
- Providing input for the design of the clinical investigation, the post-market clinical follow-up (PMCF), and the post-market surveillance (PMS) system.
- Identifying relevant and specific clinical outcome parameters for the intended clinical benefit, drawing on published clinical data related to comparable product(s).
- Defining minimum requirements for a quantified clinical benefit deemed clinically relevant, and/or identifying acceptable incidence rates of risks and adverse events.
MDCG 2020-06 – Clinical evidence for legacy devices in clinical evaluation
This document offers valuable guidance for products previously approved under the MDD and AIMD, for which a clinical evaluation must now be prepared in accordance with the MDR.
For many legacy devices, little usable data are available under the MDR. One reason is that demonstrating equivalence — and therefore relying on data from other products — has become more challenging. Another contributing factor is that, due to their simplicity, many products have scarcely been the subject of research. As a result, very few publications exist.
How, then, can compliance with the respective GSPRs — the General Safety and Performance Requirements — be demonstrated for such products?
How can “sufficient clinical evidence” be demonstrated in such a situation, particularly given that the term itself is not clearly defined?
MDCG 2020-06 defines sufficient clinical evidence as the outcome of a qualified assessment concluding that the product is safe and achieves its intended benefit. This qualified assessment is conducted as a continuous process within clinical evaluation. The MDR regards the generation and assessment of clinical data as a key element of the “life cycle approach” to medical devices.
In the first conformity assessment procedure under the MDR for a product previously certified under the MDD or AIMD, both pre-market and post-market clinical data may be used. These data must have been generated under valid MDD/AIMD certificates. However, the available clinical data may not always be sufficient under MDR requirements. For legacy devices that have undergone conformity assessment, it is assumed that they were supported by clinical data. Post-market clinical data, combined with the clinical data generated for conformity assessment under the MDD/AIMD, constitute the foundation of the clinical evaluation procedure for legacy devices under the MDR.
For all medical devices, whether approved under the MDD, AIMD, or already under the MDR, the requirements for post-market surveillance (PMS) and post-market clinical follow-up (PMCF) apply. Thus, from the date of application of the MDR, some MDR requirements also apply to legacy devices.
Why Choose Us?
Trust
Trust is one of our most important values. That's why we place great importance on the security of your data and only exchange it with you via secure servers in Germany.
Customer Satisfaction
Your satisfaction is our highest goal in all projects. For us, a project is only successful if you are satisfied!
Reliability
Do you need to solve a critical problem at short notice? Together, we can do it – even with an overnight shift if necessary. Because we are always there for our customers.
Updating a clinical evaluation
In principle, clinical evaluation must be kept up to date throughout the entire product life cycle. However, this can only be considered and justified in more detail on a product-specific basis.
The following is defined by law:
The clinical evaluation and the related documentation shall be updated throughout the product’s life cycle on the basis of the clinical data resulting from the implementation of the manufacturer’s post-market clinical follow-up plan in accordance with Annex XIV, Part B, and the post-market surveillance plan in accordance with Article 84.
For Class III devices and implantable devices, the post-market clinical follow-up evaluation report and, where applicable, the summary report on safety and clinical performance referred to in Article 32 shall be updated at least once a year on the basis of these data.
The most important laws and sources of information on the subject of “clinical evaluation” are:
- EU 2017/745, Article 61 and Annex XIV
- MDCG documents on clinical evaluation: Guidance – MDCG-endorsed documents and other guidance – European Commission
Effort, duration, and data for clinical evaluation: Summary
- The The effort required to prepare a clinical evaluation depends on the complexity of the product and the amount of data to be evaluated.
- The duration of the clinical evaluation varies depending on the availability and scope of the data.
- To prepare the clinical evaluation, we need access to parts of the technical documentation such as the instructions for use, risk management, biological assessment, PMS, PMCF, any clinical trials, and other sections. Depending on the product and project strategy, we will explain to you which data is required.
- Clinical evaluation can often be carried out without clinical testing. In this case, clinical evaluation is typically based on a systematic literature review and other data sources. We support you in developing a meaningful clinical strategy.
- The lead time for the project always depends on our available capacity and the respective project costs: Ideally, you should contact us at an early stage!
Clinical evaluation by experts: Why thinqbetter is the right partner for you
We value pragmatic, efficient solutions that are tailored to your individual needs. We take care to interpret regulatory requirements in detail in order to develop the best possible project strategy.
It is important for us to develop not only an effective but above all an efficient solution, which is generally extremely important given that medical technology is strictly regulated by law and approval costs are constantly rising, and rising sharply at that. This makes it difficult for many manufacturers to afford approvals at all. This makes it all the more important for us to help medical devices obtain approval so that the supply situation on the market does not deteriorate.
Our focus is on safe and effective medical devices and their legal compliance, not on unnecessary overinterpretation of requirements.
Our range of services in the field of clinical evaluation
Our services are primarily aimed at the target group. This includes manufacturers of medical devices or individuals and companies that wish to become manufacturers. Our services are therefore aimed at business customers (B2B).
In the field of clinical evaluation, our services include a free initial consultation as well as the following:
- Preparation of clinical evaluations for medical devices
- Updating clinical assessments
In addition, we offer further services and advice on regulatory issues.
Our qualification for clinical evaluation
We have gained many years of experience in various specialist areas by supporting over 140 different companies. This has enabled us to optimize our approach and keep project durations short while maintaining high efficiency and quality. In addition, we track project costs in detail in order to identify potential for optimization and continuously improve our workflows.
Our team comes from various scientific fields (e.g., medical technology, biology, chemistry, biotechnology, immunology) and has combined experience in research, consulting, and manufacturing.
Our employees receive ongoing and regular training to ensure they are optimally qualified for the work at hand. In addition, we use project management tools and our internal quality management system to clearly structure existing processes and project workflows and to maintain or increase efficiency and quality.
Our values
It is very important to us that our customers recognize the values we live by. We work reliably and professionally, which is why we enjoy the trust of many satisfied regular customers. Medical technology is strictly regulated, and the multitude of different requirements poses a major challenge for manufacturers. You need a strong, competent, and trustworthy partner as a consultant or service provider. As such, we are happy to assist you and ensure that your products receive reliable approval.
We encourage you to Contact us today so we can discuss how we may support you in your clinical evaluation.
Frequently asked questions
What aspects does a clinical evaluation cover?
The clinical evaluation provides clinical evidence based on the necessary data from preclinical and clinical sources. Essentially, it involves demonstrating the safety and performance of the medical device and assessing whether the product corresponds to the state of the art.
Why is the clinical evaluation of medical devices so important?
Die Zulassung eines Medizinprodukts in der EU ist ohne klinische Bewertung nicht möglich. Außerdem ist sie ein wichtiges Werkzeug zur systematischen Betrachtung des Stands der Technik und Darlegung eines akzeptablen Nutzen-Risiko-Verhältnisses.
What services do you offer in addition to clinical evaluation?
thinqbetter offers its B2B customers a comprehensive package of consulting and services covering the entire product life cycle. From product development to post-market surveillance, we provide support in almost all areas. Clinical evaluations are therefore only one part of our portfolio.
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