Services
Why choose us?
Trust
Trust is one of our most important values. That is why we attach great importance to the security of your data and exchange them with you only via secure servers in Germany.
Customer satisfaction
Your satisfaction is our highest goal in all projects. A project is only successful for us if you are satisfied!
Reliability
Do you have to solve a critical issue at short notice? Together we can do this - if necessary, even with a night shift. Because we are always available for our customers.
Clinical affairs
We provide consulting and services in the field of clinical affairs for the following topics:
- Biological evaluations
- Clinical evaluations
- Clinical investigations
- Performance evaluations
- Performance studies
Quality management
We provide consulting and services in the field of quality management for the following topics:
- EN ISO 13485
- MDSAP
- QSR / QMSR for the US market
- MDR & IVDR Article 10
Regulatory affairs
We provide consulting and services in the field of regulatory affairs for the following topics:
- Medical devices and requirements of the European markets (EU, UK, CH)
- Medical devices and requirements of the US market
- IVDs and requirements of the European markets (EU, UK, CH)
- IVDs and requirements of the US market
cONTACT US
Goal-oriented Consulting
Getting in touch with us is the first step toward solving regulatory challenges.
Let’s get started today!
Our Services
Are you looking for support in the area of regulatory services and consulting?
With us you are at the right address!
Biological evaluations
We offer consulting and services for biological evaluations. In addition to creation, updating and correction, we support you in developing efficient strategies.
Clinical evaluations
We offer consulting and services for clinical evaluations. In addition to creation, updating and correction, we support you in developing efficient strategies.
Performance evaluations
We offer consulting and services for performance evaluations. In addition to creation, updating and correction, we support you in developing efficient strategies.
PRRC-Service
We offer an external PRRC service for micro and small enterprises as defined in 2003/361/EC.
Quality management – MDSAP
MDSAP covers the quality management requirements of Australia, Brazil, Japan, Canada and the USA. We can assist you with all matters relating to this topic!
Quality management – ISO 13485
Establishment and improvement of quality management systems according to (EN) ISO 13485.
IVD Studien & MDCG
We are your reliable partner for the approval of your medical devices and IVDs!
Risk Management
Risk management is a legal requirement for medical devices and IVDs. We support you in applying EN ISO 14971 as well as in specific methods such as FMEA.
Product Registration
We are your partner for all regulatory aspects of medical devices in the USA. We support your market access – for example, with a 510(k) submission!
Are you missing a service?
Contact us!
Due to the wide range of different and multifaceted services we offer, we only list the most common services on our website.
If you require a service that is not listed above, please contact us!
Why choose us?
Trust
Trust is one of our most important values. That is why we attach great importance to the security of your data and exchange them with you only via secure servers in Germany.
Customer satisfaction
Your satisfaction is our highest goal in all projects. A project is only successful for us if you are satisfied!
Reliability
Do you have to solve a critical issue at short notice? Together we can do this - if necessary, even with a night shift. Because we are always available for our customers.
Request info
One of our consultants will contact you shortly after receiving your inquiry.
Confidentiality and discretion are important to us. Therefore, we will treat your inquiry accordingly, even before we conclude a confidentiality agreement.
