Expert in medical device standards and CE regulations
This expertise is gained in over 25 years working in various roles in the medical device industry, including 9+ years as a notified body contract Lead Auditor for DEKRA.
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News
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31 March 2020
Update harmonized standards for MDD & IVD directives
The European Commission publishes an update of harmonized standards for Medical Devices & IVD directives.
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27 March 2020
Will MDR be postponed for a year?
MDR would apply from May 26. Due to the impact of COVID-19 on national authorities and industry, the EC requests a year's delay.
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25 March 2020
Temporary supply of medical devices without CE mark
The outbreak of the corona virus can cause shortages of regular medical devices.
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