MedTech news roundup September 2022
Our September MedTech news roundup includes information from Swiss Medtech regarding increasing cost pressure on medical device manufacturing, findings from…
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Consultant Spotlight – Donovan Chie
Donovan Chie is one of our valued consultants in Operations. He’s also an accomplished sportsperson, a keen musician, and an…
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MedTech news round up August 2022
Our August MedTech news roundup covers the EU Commission’s call for EURLs, an FAQ from Swissmedic on medical devices notification,…
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MedTech news roundup July 2022
Our July MedTech news roundup includes an IVD notification FAQ from Swissmedic, MDCG guidance on interim solutions for IVDR in…
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How to calculate the Analytical Evaluation Threshold for your Biocompatibility Assessment
The Analytical Evaluation Threshold (AET) is the crucial parameter for demonstrating that your analytical results sufficiently assess the biological safety…
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MedTech news roundup June 2022
Our June MedTech news roundup includes a notice from the EU Commission on the EU-Swiss MRA status for IVDs, advice…
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MedTech news roundup May 2022
This month’s MedTech news includes guidance from the MDCG on significant changes under IVDR, new ordinances from the Swiss Federal…
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MedTech news roundup April 2022
This month’s roundup includes an update on the EU Commission’s joint implementation plan for IVDR, guidance from the MDCG on…
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