Time to recapture – Do we still need “process validation”?
September 22, 2020
We are experiencing times where regulations are getting extreme and partially overdone.
This new forum is a collection of stories from our team that talks about the changing landscape and
how companies and talents are positioning themselves.
We are experiencing times where regulations are getting extreme and partially overdone.
A live event with Elena Kyria, CEO of Elemed and Martin Witte, Global Director, Active Implantable & Cardiovascular Devices at TÜV SÜD.
Leading QA/RA experts shared their stories on how their professional life has been impacted by this unprecedented crisis.
The National Standards Authority of Ireland is the 11th Notified Body designated under MDR…
DNV GL Presafe AS of Norway is the 10th Notified Body to be designated under MDR…
Elena Kyria speaks to Regulatory Rapporteur about the current status of the medical devices job market…
According to SWISS MEDTECH, the worst case scenario is realistic…
MedTech Europe warns of potential “cliff-edge scenario” if European Commission fails …
ABHI describes the Notified Body capacity issue as a “crisis”, in a letter to their members …
COCIR delivers a scathing public feedback on the draft standardisation request for the MDR and IVDR….
Elena Kyria is an award winning talent acquisition specialist in the Medtech industry. She has worked with hundreds of professionals in Regulatory, Quality and Clinical roles in Europe, over the last 9 years. Elena is on the leadership team for RAPS (Regulatory Affairs Professionals Society) Swiss chapter, a member of the Healthcare Businesswomen’s association, career and professional branding coach, founder and moderator of the EU Medical Device Regulation Update Forum, and a speaker at industry events. In 2018, Elena was named one of the year’s top Millennial Shepreneurs by Insights Success Magazine.
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