MedTech news round up March 2021
Our MedTech news for March 2021 covers MDR updates from Europe & the UK, an insightful piece on leveraging real-world evidence in regulatory…
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Consultant Spotlight – Dr Silvio Peng
Dr Silvio Peng joined us in October 2020 as a Consultant in Operations. Microbiologist, biocompatibility specialist, sports fan and owner…
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3 steps to Classifying Medical Devices in the US
The process of classifying a medical device in the US involves reviewing the potential regulatory class (I, II or III),…
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3 steps to Classifying Medical Devices in the EU
To classify a medical device in the EU, the intended use needs to be articulated, before defining and categorising the…
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MDSAP – When to join the program
Based on ISO 13485:2016, MDSAP (Medical Device Single Audit Program) is an audit program that allows for a single regulatory…
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MedTech news round up February 2021
Our MedTech news for February 2021 covers the EU Commission’s new information on the management of legacy devices and IVDs,…
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Consultant Spotlight – Leah Kidney
Leah Kidney is one of our valued consultants in Quality. She’s also an ex-Gaelic Football star, keen traveller and aspiring…
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MedTech news round up January 2021
January 2021 has been a busy month for the industry, with updates to standards, new guidance releases and measures taken…
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