Medical device regulations are becoming increasingly complex, posing a real challenge to the whole medical device industry, particularly manufacturers, importers and distributors. European Biomedical Institute has been monitoring the recent developments to offer you expert advice tailored to your needs and help you prepare the required approval documents. We support all companies, paying special attention to the implementation of the relevant requirements.
– consulting services for product development and compliance with MDR (EU) 2017/745
– gap analysis and strategic advice to close the identified gaps
– full-service biological evaluation of medical devices in accordance with ISO 10993-1
– literature search and supply service for clinical evaluations and further need
European Biomedical Institute is Good Laboratory Practice (GLP) certified, ISO 17025 accredited, and US FDA 21CFR58 compliant. Our institute also provides biocompatibility testing services in the field of certification services. Thanks to these services, enterprises are able to produce more efficient, high-performance and high-quality products in a safe, fast and uninterrupted manner.
Together, we can develop a strategy best fitted to your needs. Learn how our experts can help you to adopt the MDR requirements to your company with a minimum of effort.
For further information, please contact your sales representative team if you’re an existing customer or if you’re new to European Biomedical Institute please reach us.
We look forward to helping you reach all of your evaluation goals and a successful submission!