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As Europe moves into the summer…

This week parts of Europe saw the first nice, warm and sunny days of the year, as it has been an exceptionally wet and rainy year so far. Let’s hope that the same transition is ahead of us in the medical device and IVD regulatory space!

IVDR MDR 2017/745

Navigating MDR Challenges: How Qserve's Interim Support Can Optimize Your Medical Device Compliance

Explore how the European Union’s Medical Device Regulation (MDR) revolutionizes safety standards for medical devices while challenging companies' resources, and discover how interim support can be a game-changer in navigating these stringent new requirements.

Medical Device Regulations Medical Devices Interim Support Medical Device Compliance

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September 06, 2024

On-Demand Webinar | Common Pitfalls to Avoid for Medical Device Startups

Watch the on-demand webinar to learn about the most common pitfalls that medical device startups encounter—and more importantly, how to avoid them.

Medical Device Regulations On-Demand Webinar Startups

September 04, 2024

Key Strategies for Successfully Passing NMPA Inspections for Medical Device Manufacturers | Part 7. China NMPA Inspection results and common findings

The NMPA (National Medical Products Administration) is responsible for regulating medical devices in China. In Part 7 of our blog series, we explore the most common findings from NMPA inspections and offer key insights for manufacturers to strengthen their quality systems. By understanding these frequent issues, such as design and development or production management, manufactures can better prepare for inspections and ensure compliance with NMPA regulations.

China Medical Devices NMPA

August 28, 2024

Registration progress, MDSAP and the latest regulatory developments in Canada

Blog Global Registration MDSAP Medical Device Registration Medical Device Regulations Regulatory News

Q&A | Impact of the EU AI Act on Medical Device and IVD Manufacturers

Watch this Q&A where Software and AI Expert Coenraad Davidsdochter answers top-asked questions about the EU AI Act, a proposed regulation by the European Commission to ensure AI systems in the EU are safe, transparent, and uphold fundamental rights, potentially setting a global benchmark for AI governance.

Navigating Regulatory Compliance and Quality Assurance: Due Diligence of Medical Device Companies

In the rapidly evolving healthcare landscape, regulatory compliance and quality assurance are crucial for medical device companies, and involving experts like Qserve in due diligence can help identify compliance issues, mitigate risks, and ensure product safety, thereby aiding investment companies in making informed acquisition decisions.

Medical Devices Quality Assurance

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