RAQA Today

Everything you need to know about biocompatibility - in one podcast.

From a webinar hosted by MedTech Leading Voice and featuring Michelle and Marina Daineko from Intrinsic Medical Group.

𝗕𝗶𝗼𝗰𝗼𝗺𝗽 𝟭𝟬𝟭: 𝗙𝘂𝗻𝗱𝗮𝗺𝗲𝗻𝘁𝗮𝗹𝘀 𝗳𝗼𝗿 𝗠𝗲𝗱𝗧𝗲𝗰𝗵 𝗣𝗿𝗼𝗳𝗲𝘀𝘀𝗶𝗼𝗻𝗮𝗹𝘀

By understanding biocompatibility and following best practices, manufacturers can ensure the safety and efficacy of their medical devices:

- Biocompatibility involves material selection, device design, testing, and risk management.
- Direct and indirect contact with the body are key considerations.
- Regulatory requirements and risk assessment are essential.
- Material selection can be challenging due to potential adverse reactions.
- Device design must minimize the risk of complications.
- Testing limitations and regulatory compliance can be complex.

𝗕𝗮𝘀𝗶𝗰𝘀 𝗼𝗳 𝗕𝗶𝗼𝗰𝗼𝗺𝗽𝗮𝘁𝗶𝗯𝗶𝗹𝗶𝘁𝘆
What is assessed, when is it assessed

𝗖𝗮𝘀𝗲 𝗦𝘁𝘂𝗱𝘆 #𝟭
- IEC standard 60601-1
- ISO 14971
- ISO 10993

𝗖𝗮𝘀𝗲 𝗦𝘁𝘂𝗱𝘆 #𝟮
- Testing connector cables for leachables

𝗖𝗮𝘀𝗲 𝗦𝘁𝘂𝗱𝘆 #𝟯
- Intended Use vs Depicted Use
- Costs and documentation changes arising from failed biocompatibility testing

𝗠𝗲𝗱𝗶𝗰𝗮𝗹 𝗗𝗲𝘃𝗶𝗰𝗲 𝗖𝗵𝗮𝗻𝗴𝗲𝘀 𝗥𝗲𝗾𝘂𝗶𝗿𝗶𝗻𝗴 𝗕𝗶𝗼𝗰𝗼𝗺𝗽𝗮𝘁𝗶𝗯𝗶𝗹𝗶𝘁𝘆 𝗧𝗲𝘀𝘁𝗶𝗻𝗴

𝗖𝗮𝘀𝗲 𝗦𝘁𝘂𝗱𝘆 #4
- Heat changes chemistry, which means biocompatibility testing

𝗕𝗶𝗼𝗰𝗼𝗺𝗽𝗮𝘁𝗶𝗯𝗶𝗹𝗶𝘁𝘆 𝗧𝗲𝘀𝘁𝗶𝗻𝗴 𝗘𝘅𝗲𝗺𝗽𝘁𝗶𝗼𝗻𝘀 𝗮𝗻𝗱 𝗪𝗵𝗲𝗻 𝗧𝗵𝗲𝘆 𝗔𝗽𝗽𝗹𝘆

𝗠𝗮𝗻𝗮𝗴𝗶𝗻𝗴 𝗕𝗶𝗼𝗰𝗼𝗺𝗽𝗮𝘁𝗶𝗯𝗶𝗹𝗶𝘁𝘆 𝗥𝗲𝗾𝘂𝗶𝗿𝗲𝗺𝗲𝗻𝘁𝘀 𝗯𝘆 𝗖𝗼𝘂𝗻𝘁𝗿𝘆
- Animal testing
- Biocompatibility testing labs
- ASCA program

𝗖𝗼𝗻𝘁𝗮𝗰𝘁 𝗗𝘂𝗿𝗮𝘁𝗶𝗼𝗻