MedQAIR’s Journey: Founding Story, Mission, and What Sets Us Apart (Q&A) Regulatory compliance in the medical device industry is ever-evolving,
MedQAIR’s Journey: Founding Story, Mission, and What Sets Us Apart (Q&A) Regulatory compliance in the medical device industry can feel
Navigating the e-QMS Landscape: Insights from the European SaMD Meetup Ivo Flipse from MedQAIR co-hosted the European SaMD Meetup alongside
Compliance with the Medical Device Regulation (MDR) and In-Vitro Medical Regulation (IVDR) is crucial in the complex and highly regulated
As an Authorised Representative (AR) in the European Union (EU), the role encompasses critical responsibilities regarding the management of manufacturer
On May 26, 2021, the Medical Device Regulation (MDR) 2017/745 went into full effect. One of the key changes included
Co-authored with Preethi Philip Under the MDD 93/42/EEC, the medical device industry lacked a serious level of transparency in the
Manufacturers who are not based in the EU have to rely on an Authorised Representatives if they wish to introduce
Under the MDD 93/42/EEC, the role of the medical device Distributor was largely unaddressed in the Medical Device legislation within
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