Biological Safety

Evaluating biological safety

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. Testing may be required to verify biological safety of the device. Evaluation and testing are most conveniently performed following ISO 10993, a standard series which is planned to be harmonized with Regulations 2017/745 (MDR) and 2017/746 (IVDR) and already is in a recognised consensus standard list of US FDA.  

 How can we help?

• Planning the biological safety evaluation process in accordance with applicable standards and regulations
• Helping you implement and maintain the biological safety evaluation process
• Preparing biological safety evaluation plans and reports
• Evaluating existing data on biological safety and choosing the correct test pattern based on the data
• Risk analysis covering biological safety aspects
• Contacting test facilities and arranging chemical and biological testing
• Interpretation of the test results
• Offering toxicological expertise through our co-operation network
• Helping you answer biological safety related questions raised by notified bodies and authorities
• Offering customized training for biological safety evaluation