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ATTENTION: fake certificates
By Katarzyna Mizerska on 14. June 20210Read moreUnfortunately, we were informed about fake MEDCERT certificates. Please note that these certificate were neither issued by MEDCERT nor...
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EU: New MDCG document Q&A on custom-made devices
By Katarzyna Mizerska on 14. June 2021Read moreThe MDCG has published a new document on custom-made devices. This Q&A is a high-level document aimed at addressing...
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EU: New MDCG Documents on Clinical investigation
By Katarzyna Mizerska on 14. June 2021Read moreThe Medical Device Coordination Group (MDCG) has established a series of clinical investigation application/notification documents to support clinical investigation...
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EU: EUDAMED – new documents from the European Commission and MDCG
By Katarzyna Mizerska on 14. June 2021Read moreOn 15 February 2021, the European Commission published guidance on the management of legacy devices in EUDAMED. This guidance...
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EU: Is your software a medical device? An infographic
By Katarzyna Mizerska on 14. June 2021Read moreThe Medical Device Coordination Group (MDCG) has recently published a new infographic on medical device software. The graphic should...
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EU: How to master a MDR challenge – experts in the LSN Magazine
By Katarzyna Mizerska on 14. June 2021Read moreIn the newest article in the LSN– Life Science Nord Magazine you can read about how established medical technology...
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EU: MDR Initial Conformity Assessment Process as a Chart
By Katarzyna Mizerska on 4. June 2021Read moreWe are happy to introduce you the new, easy to understand overview of the MDR-Initial Conformity Assessment Process. As...
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EU: UDI – Helpdesk and a new MDCG Guidance
By Katarzyna Mizerska on 4. June 2021Read moreThe European Commission has launched a new helpdesk to support implementing the requirements introduced by the new Unique Device...
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