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 Work with Us
- You benefit from our years of experience in medical device registration
- With us, you can quickly and reliably open up new markets.
- Your project success is ensured by our experts.
- Your satisfaction is our most important goal.
Our experts support you with the registration of medical devices from Class I to III.
With thinqbetter, you have a partner who supports you in your project in a straightforward and reliable manner.
Our Services
With thinqbetter, you can open up new markets as quickly as possible, so your products reach even more patients!
We support you with the registration of your medical device or IVD.
We compile the registration documents for your FDA Submission.
We support you with global registration!
Registration Europe
For the registration of your medical devices, the Medical Device Regulation (MDR) is authoritative. It describes various conformity assessment procedures, i.e., registration procedures for medical devices.
- Conformity assessment based on a quality management system and an evaluation of the technical documentation
- Conformity assessment based on a type examination
- Conformity assessment based on product conformity verification
Technical Documentation
The basis for registration is the technical documentation (TD) according to Annex II and Annex III. It contains the evidence (physical or by reference) for compliance with the requirements of both annexes and the general safety and performance requirements according to Annex I.
After successfully completing one of the various conformity assessment procedures, the medical device is registered. Only then can the CE mark be affixed.
CE Mark
By affixing the CE mark, the manufacturer declares that the product complies with the applicable requirements for affixing the CE mark as laid down in the Community harmonization legislation. In relation to the MDR, this means the manufacturer declares compliance with the applicable requirements for the medical device.
The symbol is shown in Annex V of the MDR. The underlying grid indicates the relative dimensions to be observed.
Registration USA
For product registration in the USA, in addition to the actual registration procedures, there are a number of formal requirements to observe. But don’t worry, we support you in all aspects of market access!
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.
Facility and Product Registration
In the USA, a so-called “Facility Registration”“and a “Device Listing”” must be carried out before products can be distributed there. This is a formal step where we can support you – so you don’t lose valuable time on your way to US market access.
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Effective Consulting
Getting in touch with us is the first step towards solving regulatory challenges.
Let’s get started today!
Premarket Notification 510(K)
Just as described in the previous paragraph, this is a reference to the FD&C Act. It describes the registration method for a “Premarket Notification”. This is a very common procedure for registering products in the USA.
While the basic creation of a 510(k) is more or less identical for all products, it is quite specific due to many product-specific guidance documents and various 510(k) forms.
A so-called “Predicate Device” serves as the basis for a 510(k), with which one’s own product is compared. Based on this comparison, “Substantial Equivalence” must be demonstrated. Once this is achieved, the product can be registered through it.
- How to find a Predicate Device?
- What structure does a 510(k) need?
- What evidence must be attached?
- How is Substantial Equivalence demonstrated?
For these and many other questions on the topic, we offer not only expertise but also active support in preparing your registration documents.
ISO 10993 Series of Standards
- ISO 10993-1 Biological evaluation
- ISO 10993-2 Animal welfare requirements
- ISO 10993-3 Genotoxicity, carcinogenicity and reproductive toxicity
- ISO 10993-4 Interaction with blood
- ISO 10993-5 In vitro cytotoxicity
- ISO 10993-6 Local effects after implantation
- ISO 10993-7 Ethylene oxide sterilization residuals
- ISO 10993-9 Identification and quantification of potential degradation products
- ISO 10993-10 Skin sensitization
- ISO 10993-11 Systemic toxicity
- ISO 10993-12 Sample preparation and reference materials
- ISO 10993-13 Qualitative and quantitative detection of degradation products
- ISO 10993-14 Qualitative and quantitative detection of ceramic degradation products
- ISO 10993-15 Qualitative and quantitative detection of degradation products from metals and alloys
- ISO 10993-16 Design and interpretation of toxicokinetic studies regarding degradation products and leachable substances
- ISO 10993-17 Determination of allowable limits for leachable substances
- ISO 10993-18 Chemical characterization of materials
- ISO/TS 10993-19 Physico-chemical, morphological and topographical characterization
- ISO 10993-20 Principles and methods for immunotoxicological testing
- ISO/TR 10993-22 Guidance on nanomaterials
- ISO 10993-23 Test for irritation
- ISO/TR 10993-33 Guidance on genotoxicity testing – Supplement to ISO 10993-3
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.
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Confidentiality and discretion are important to us. Therefore, we will treat your inquiry accordingly, even before we conclude a confidentiality agreement.
