Issue 17: Exciting MLV Milestones

Issue 17 marks some exciting milestones for MLV: As of this week, we are at 🔥 2606 subscribers 🔥 205 LinkedIn posts shared 🔥 From 117 different Contributors 🔥 10 New Leading Vo

In this Issue

From the Editor ✍🏽 | In-Brief💥 | Featured Interview ▶️ | Sections ✅ | Postscript 🐝

From the Editor ✍🏽

Issue 17 marks some exciting milestones for MLV:

As of this week, we are at 🔥 2606 subscribers 🔥 205 LinkedIn posts shared 🔥 From 117 different Contributors 🔥 10 New Leading Voices 🔥 6 Exclusive Interviews 🔥 2 Sponsors 🔥 Are you next?

In Brief 💥

Parul Chansoria shared a description of the challenge of a lack of cross-functional understanding of regulations

A Breakdown of Cybersecurity Essentials by Vivek Thakkar spells out the importance of understanding the regulatory landscape, cybersecurity risks, risk assessment, and threat modeling in early-stage FDA meetings

Marina Daineko provided an insightful summary of proposed changes to the standard ISO 10993-17, guiding medical device toxicological risk assessments

🎥 Combination Products: Subhi Saadeh shared a podcast with Aaron Snyder, MSc, cGMP, explaining the foundational differences between Device QMS requirements and the Pharma cGMP's

George Zack unpacks some new twists in an extensive FDA Warning LetterA new article by Martin King breaks down the Compliance Process, one step at a time

Dr. Pushpinder Paul shared a chart summarizing the differences in regulatory requirements among the US, EDU, India, China, Japan & Brazil

A popular post by Mahesh Uppara discussed the importance of traceability and documentation in medical devices

🚀 Avisek Ghose summarized a new market research report that predicts explosive growth in the global AI-IVD market

Harshit Bhoraniya shared a recently published MHRA Guidance to help determine if your product qualifies as a medical device and which risk class it falls under.

A new Guidance Document explaining the main features of Part IV of the Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002) was shared by Matt Burton

Kamal McCray recommends software to simulate real-world conditions digitally to reduce the costs and risks in MedTech product development

Mike Wetherington shared clear and helpful instructions for doing a Root Cause Analysis

An interesting article on the use of synthetic data for AI/ML training was shared by Eric Henry

Finally, straight-forward tips on Quality Management were shared by Naveen Agarwal

Featured Interview ▶️

Click to read the exclusive interview

Last week MLV featured a short video with Ajda Mihelčič from Obelis Group, discussing the myriad of laws, regulations, guidances, and standards MedTech manufacturers need to navigate to sell their products in the EU.

This week, we go even deeper, presenting the entire featured interview with Ajda, in which she answers some important questions:

What regulatory changes are occurring in Europe, and how do they affect medical device companies?

What’s the role of the European Authorized Representative?

What are the liability issues for the responsible person

Do you also need a representative in each country?

What pitfalls do manufacturers encounter either with the regulations or the authorized representative?

What advice would you give non-EU manufacturers about evaluating the competency of an authorized representative?

Any predictions for the future with AI?

Read the interview >>

Sections ✅

✅ Weekly Regulatory Roundup

By Martin King, July 17, 2023

Click the Index to read the Regulatory Roundup

In This Week's Regulatory Roundup

🔥 New updates from the European Medicines Agency, European Commission, Therapeutic Goods Administration, Egyptian Drug Authority, Medicines and Healthcare Products Regulatory Agency, IEC (International Electrotechnical Commission), and US FDA

Postscript 🐝

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

Sean 🐝

---

*Archived by Hermes*