In this blog, guest blogger, Katarzyna Wesołowska, Chief Executive Officer at MDR Regulator, explained How to build an effective MDR strategy for cooperation with Importers, Distributors and Authorised representatives?
In this blog, guest blogger Elly Gysels, Head Regulatory Affairs at Sensile Medical, explains product documentation: why you care about it and how to improve it.
In this blog, guest blogger Christian Weckert, Regulatory Affairs Manager at Ypsomed AG, explains how a focus on outcomes makes you agile.
Risk Management sets the level of effort expected to be put into the Quality Management ecosystem. It is the systematical approach to identity, evaluate, respond/control, and accept risk.
In this blog, Dr. Nadine Leistner, Chief Scientific Officer of the MEC-ABC GmbH, shares 6 steps through the clinical part for CE certification.
Are decentralized clinical investigations the future standard for Medical Device clinical operations – or is it just a buzz?
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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