Latest Blog Posts
Navigating MDR: Fresh Insights and Updates
EU AI Act: Key Implications for Healthcare and MedTech
A new paper titled “The AI Act: responsibilities and obligations for healthcare professionals and organizations,” published in Diagnostic and Interventional Radiology, offers a detailed analysis
Meet the Team: Jorrit Boersen
We’re excited to welcome Jorrit Boersen to the MedQAIR team as our newest Consultant. With a strong background in Technical Medicine and a focus on
Meet the Team: Willibrord Driessen
MedQAIR’s Journey: Founding Story, Mission, and What Sets Us Apart (Q&A) Regulatory compliance in the medical device industry is ever-evolving, especially with the rise of
Meet the Founders #2: Leon Doorn
MedQAIR’s Journey: Founding Story, Mission, and What Sets Us Apart (Q&A) Regulatory compliance in the medical device industry is ever-evolving, especially with the rise of
Meet the Founders #1: Ivo Flipse
MedQAIR’s Journey: Founding Story, Mission, and What Sets Us Apart (Q&A) Regulatory compliance in the medical device industry can feel like a maze—complex, time-consuming, and
Navigating the e-QMS Landscape: Insights from the European SaMD Meetup
Navigating the e-QMS Landscape: Insights from the European SaMD Meetup Ivo Flipse from MedQAIR co-hosted the European SaMD Meetup alongside Lara Rashdan from hema.to. In
Choosing Your PRRC and Authorised Representative for Effective Collaboration
Compliance with the Medical Device Regulation (MDR) and In-Vitro Medical Regulation (IVDR) is crucial in the complex and highly regulated medical device landscape of the
The Role of an Authorised Representative in Managing Manufacturer Data and Completing EUDAMED Registrations
As an Authorised Representative (AR) in the European Union (EU), the role encompasses critical responsibilities regarding the management of manufacturer data and the completion of
EUDAMED and Other International Regulations. Exploring Connections and Comparisons.
On May 26, 2021, the Medical Device Regulation (MDR) 2017/745 went into full effect. One of the key changes included the introduction of enhanced traceability
