ZERO to BIOCOMP: Biocompatibility 101 for MedTech Professionals

Описание: Everything you need to know about biocompatibility - in one video.

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

𝗕𝗶𝗼𝗰𝗼𝗺𝗽 𝟭𝟬𝟭: 𝗙𝘂𝗻𝗱𝗮𝗺𝗲𝗻𝘁𝗮𝗹𝘀 𝗳𝗼𝗿 𝗠𝗲𝗱𝗧𝗲𝗰𝗵 𝗣𝗿𝗼𝗳𝗲𝘀𝘀𝗶𝗼𝗻𝗮𝗹𝘀 (6:26)

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 (6:30)
What is assessed, when is it assessed,

𝗖𝗮𝘀𝗲 𝗦𝘁𝘂𝗱𝘆 #𝟭 (11:37)
IEC standard 60601-1
ISO 14971
ISO 10993

𝗖𝗮𝘀𝗲 𝗦𝘁𝘂𝗱𝘆 #𝟮 (14:07)
Testing connector cables for leachables

𝗖𝗮𝘀𝗲 𝗦𝘁𝘂𝗱𝘆 #𝟯 (16:26)
Intended Use vs Depicted Use
Costs and documentation changes arising from failed biocompatibility testing

𝗠𝗲𝗱𝗶𝗰𝗮𝗹 𝗗𝗲𝘃𝗶𝗰𝗲 𝗖𝗵𝗮𝗻𝗴𝗲𝘀 𝗥𝗲𝗾𝘂𝗶𝗿𝗶𝗻𝗴 𝗕𝗶𝗼𝗰𝗼𝗺𝗽𝗮𝘁𝗶𝗯𝗶𝗹𝗶𝘁𝘆 𝗧𝗲𝘀𝘁𝗶𝗻𝗴 (21:05)

𝗖𝗮𝘀𝗲 𝗦𝘁𝘂𝗱𝘆 #𝟰 (22:09)
Heat changes chemistry, which means biocompatibility testing

𝗕𝗶𝗼𝗰𝗼𝗺𝗽𝗮𝘁𝗶𝗯𝗶𝗹𝗶𝘁𝘆 𝗧𝗲𝘀𝘁𝗶𝗻𝗴 𝗘𝘅𝗲𝗺𝗽𝘁𝗶𝗼𝗻𝘀 𝗮𝗻𝗱 𝗪𝗵𝗲𝗻 𝗧𝗵𝗲𝘆 𝗔𝗽𝗽𝗹𝘆 (24:10)

𝗠𝗮𝗻𝗮𝗴𝗶𝗻𝗴 𝗕𝗶𝗼𝗰𝗼𝗺𝗽𝗮𝘁𝗶𝗯𝗶𝗹𝗶𝘁𝘆 𝗥𝗲𝗾𝘂𝗶𝗿𝗲𝗺𝗲𝗻𝘁𝘀 𝗯𝘆 𝗖𝗼𝘂𝗻𝘁𝗿𝘆 (27:25)
Animal testing
Biocompatibility testing labs
ASCA program

𝗖𝗼𝗻𝘁𝗮𝗰𝘁 𝗗𝘂𝗿𝗮𝘁𝗶𝗼𝗻 (39:14)

𝗙𝗶𝗻𝗮𝗹 𝗧𝗵𝗼𝘂𝗴𝗵𝘁𝘀 (42:39)