Team Lead, Quality and Regulatory Affairs
Labquality provides medical device manufacturers help with setting up a biological safety evaluation process and preparing biological evaluation documentation for their medical products.
Biological safety needs to be evaluated for every medical device and in vitro diagnostic medical device which contains parts or materials that have patient contact.
This is most conveniently performed following ISO 10993, a standard series to be harmonized with Regulations 2017/745 (MDR) and 2017/746 (IVDR).
✔ Planning the biological safety evaluation process together with the manufacturer in accordance with applicable standards and regulations
✔ Helping the manufacturer to implement and maintain the biological safety evaluation process
✔ Preparing biological safety evaluation plans and reports
✔ Helping the manufacturer with risk analysis covering biological safety aspects
✔ Evaluating existing data on biological safety and helping the manufacturer in choosing the correct test pattern based on the data
✔ Contacting test facilities and arranging chemical and biological testing
✔ Helping the manufacturer in the interpretation of the test results
✔ Offering toxicological expertise through our co-operation network
✔ Helping the manufacturer in answering the biological safety related questions raised by notified bodies and authorities
✔ Offering customized training for biological safety evaluation
Efficient introduction – Regulatory Essentials in Health Tech – training series >>