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Whirlwind of Change: How New Standards, MDR, and Brexit are Impacting Biocompatibility

Because of the COVID-19 crisis, new Medical Device Regulations (MDR) have been pushed back one year. Not only has the delay given a respite to companies not ready for increased regulations but also has put the new MDR requirements in the same time period with the impact of Brexit and new ISO 10993 requirements. This Tech Talk discusses the current status of biocompatibility submission with MDR and Brexit and explains what others are doing to get ready.