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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21 February 2020
NSAI 11th Notified Body MDR
Last week the Nando website showed that NSAI (National Standards Authority of Ireland) is designated as the 11th Notified Body under the EU-MDR.
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14 February 2020
"Worst case scenario" MDR and MDD realistic for third countries?
Third country compliance for Swiss manufacturers for all products under MDR and MDD from 26 May 2020 is currently the realistic «worst-case scenario».
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12 January 2020
MDCG 2019-15 Guidance Notes Class I Medical Devices
MDCG 2019-15 Guidance Notes For Manufacturers of Class I Medical Devices
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