13 Essential MedTech Updates

In this Issue

From the Editor ????| In-Brief?? | Sections ? | Postscript ??

From the Editor????

On a morning bike ride in Villa Borghese, a large public park in Rome, I was thinking about the essence of this week's posts. Although the topics vary, what they have in common is an "essential quality" that makes them all worth reading.

Plus, the newest MedTech Leading Voice, Mahesh Uppara, and the always-helpful Regulatory Roundup by Martin King.

Don't forget to read the PS ??

In Brief ??

• 10 important blogs for learning quality assurance and quality management, from Harsh Thakkar
• Mahesh Uppara posted a concise guide to understanding biocompatibility testing in medical device manufacturing?
• An interesting new study about AI/ML capabilities in marketing was shared by Martin King
• Two recent FDA Warning Letters, shared by Eric Henry, point to the sometimes fine line between device and non-device functionality
• Stefano Bolletta posted an insightful article on the EU AI Act
• A detailed template for CEP legacy devices was shared by EU MDR Compliance
• Mike Wetherington discussed the need for accurate identification, interpretation, and integration of essential standards into the device design cycle are pivotal for success.
• 10 Guidance links related to the implementation of future medical devices regime were shared by Matt Burton
• An update about the MHRA timelines for CE-marked devices was underscored by Kurt Dennis
• Sandeep Bains compiled and shared some key information you need to know about UKCA Markings
• Antonio Bartolozzi contrasted the US and EU explanations of Electronic Patient Record Systems
• Michelle Raley posted a worthwhile article on QMS requirements for pharma companies?
• Finally, a new blog post by Joseph Turton explains the top 5 common pitfalls of Computerized System Validation

Sections ?

??New MedTech Leading Voice

Mahesh Uppara, MBA is the Program Director of Fallouh Healthcare , a Medical Device start-up company developing a medical device used for monitoring patients following cardiac surgery. With over 15 years of experience in Program Management, he has developed a comprehensive plan that outlines timelines and milestones for projects, ensuring they stay on track and within budget.

His helpful posts talk about the medical technology industry in ensuring quality and safety.

When it comes to the design and development of medical devices, meeting technical specifications and requirements, and ensuring required quality standards, Mahesh is an expert. He also talks about empowering medical device professionals to excel in their role and how to foster innovation.

??Weekly Regulatory Roundup

By?Martin King, July 10, 2023

In This Week's Regulatory Roundup

???New updates from?European Medicines Agency,?European Commission, Therapeutic Goods Administration, Egyptian Drug Authority, Medicines and Healthcare Products Regulatory Agency,?IEC (International Electrotechnical Commission), Swissmedic, and World Health Organization WHO

Postscript ??

Do you struggle to connect with active MedTech decision-makers? Contact me to learn about new MLV Webinars and other sponsorship opportunities.

Sean ??