Ready for the MDR? We support you with documentation and assessment for your medical devices, covering biocompatibility, sterilization, reprocessing, packaging, and shelf life.
Based on our years of experience in the medical devices sector, we can competently support you in evaluating the biological safety of your products. Utilizing current regulations, guidelines, standards, and the state of the art, we develop a testing strategy tailored to your products and needs, helping you use time and costs more effectively and achieve the best possible results for certification in the (inter-)national market. Additionally, we can assist with production hygiene, sterilization, and reprocessing of your reusable products. We are also happy to train you in a workshop at your location, through our webinars, or in a seminar at Eurofins in Munich.
Why choose Eurofins Medical Device Consulting?
We have 25 years of experience in biological safety testing for medical devices, and our experts participate in technical committees (DIN, ISO, HAK RDS) and regularly attend training events from DGPT, external seminars, internal and external webinars, and scientific conferences. We offer a network of scientists and experts ready to support you.
Eurofins Medical Device Consulting aims to assist you with your complex tasks. Our services include:
- Biocompatibility of Medical Devices and Combination Products:
- Global regulatory strategy consulting
- Biological Test Plan (BEP) and Report (BER) according to ISO 10993-1
- Verification of study validity
- “Bridging Approach” (e.g., after manufacturing changes)
- Creation of certificates (ISO and USP)
- Risk assessment of extractables and leachables (according to ISO 10993-17)
- Evaluation of biological and toxicological risks
- Evaluation of unexpected data (e.g., positive cytotoxicity)
- Regulatory Affairs:
- Creation of technical documentation (e.g., according to MDR, 510(k) submissions)
- Establishment of a Quality Assurance System according to ISO 13485
- Reprocessing:
- Support and optimization of user instructions
- Risk analysis
- Development of a testing strategy
- Support with unexpected results
- Packaging, Stability, and Shelf Life:
- Support in selecting packaging materials and configurations
- Regulatory support
- Development of a testing strategy for packaging validation
- Planning stability testing over the shelf life
- Determination of required endpoints (physicochemical parameters, biocompatibility, microbiology, functionality, etc.)
- Support in evaluating test results
- Eurofins Training Academy:
- In-house or corporate training
- Webinars
- Updates on guideline
For more information on our services for documentation and assessment of medical devices, please visit our website (DACH region or worldwide).
