Preparing for Medical Device Audits

MedTech Leading Voice - Issue 8

Preparing for Medical Device Audits

Sean Smith

Founder & Publisher | MedTech, Life Sciences, HealthTech | MDR/IVDR, QA/RA | Leading Voice Program | Worker 🐝

May 18, 2023

In this Issue

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

From the Editor ✍🏽

This week's issue has new posts audits, CAPA, Cybersecurity, MDSAP, AI, SaMD, RAPS, and more. It also features an interview with MedTech Leading Voice contributing Editor Mitch Robbins about hiring remote regulatory teams.

In Brief 💥

A popular post by Karandeep Singh Badwal discussed why many medical device audits don't have the desired outcome.

Martin Witte posted a short video interview with Jan Küfner about Cybersecurity requirements in the EU, including two useful documents on audits and technical documentation.

A recent BSI post by Eamonn Hoxey details updates to the Medical Device Single Audit Program (MDSAP) audit approach document.

A post by EU MDR Compliance underscored why a robust CAPA process should focus on investigating and understanding the root cause of the problem.

Stefano Bolletta posted MDCG 2020-3 Rev., a new Guidance on significant changes regarding the transitional provision under Article 120 of the MDR covering legacy devices.

A new EU MDR guidance document from the European Commission, posted by Jon Bergsteinsson, details how to structure and summarize a clinical investigation report.

Rebecca Stevens posted the new BSI White Paper on Ethical and trustworthy Artificial Intelligence, an introduction to the European Artificial Intelligence Draft Act (AIA).

Ricard Holborow posted a high-level summary of key takeaways from RAPS Euroconvergence conference last week in Amsterdam.

Marina Daineko posted a succinct breakdown of the RAPS Euroconvergence discussion of the regulatory challenges companies face regarding Software as a Medical Device (

hashtag

#SaMD).

Matt Burton posted that the European Parliament has moved a step closer to enacting a new Artificial Intelligence Act aiming to ensure that AI systems are overseen by people, are safe, transparent, traceable, non-discriminatory, and environmentally friendly.

In a recent review of five FDA-approved AI/ML-enabled devices, Naveen Agarwal explored how artificial intelligence is advancing innovation in the medical device industry.

Lesley Worthington posted some excellent advice for getting management buy-in on Quality discussions and initiatives.

During a recent Podcast by Harsh Thakkar featuring Marcus Emne, CEO of Hoodin, Emne discussed how their automated content monitoring platform for RA and QA professionals to have global regulatory updates data at their fingertips.

A useful overview chart by David Rutledge summarizes the European Commission's Guidance On the Content and Structure of the Summary of the Clinical Investigation Report and its implications for the industry.

Featured Interview ▶️

Click to watch the video interview

Hiring Remote Medical Affairs Talent

Last week, MLV had the pleasure of speaking with MedTech Recruiter Mitch Robbins, Founder and Managing Director of The Anthony Michael Group, about the considerations for hiring a remote regulatory affairs team and what most prospective regulatory affairs hire want. Watch the video or read the full interview.

Highlighted Posts 🔥

Click to view the post

Cybersecurity Requirements in the EU

A recent video post with Martin Witte and Jan Küfner from TÜV SÜD discussing cybersecurity requirements in the EU. Plus, significant insight into what Notified Bodies might want to see during an audit and technical documentation assessment.

Click to view the post

Clinical Investigation Report Guidance

David Rutledge has created a chart summarizing the key takeaways from the European Commission's new guidance document: "Commission Guidance On the Content and Structure of the Summary of the Clinical Investigation Report."

Sections ✅

✅ New MedTech Leading Voice

Matt Burton is a principal consultant and QA/RA professional with over 25 years of experience within the MedTech and Pharma sectors. His expertise encompasses development, manufacture, distribution, and lifecycle management. With an educational background in chemistry, he began his career as a chemist and transitioned to regulatory affairs.

His LinkedIn posts are a mix of regulatory updates, new guidance documents, especially from the UK, and original articles covering various topics.

✅ Weekly Regulatory Roundup

By Martin King, May 15, 2023.

Click to view Regulatory Roundup

In This Week's Regulatory Roundup

Updates from: European Commission, European Medicines Agency, FDA. MDSAP, IMDRF, Medicines and Healthcare products Regulatory, Agency, Swissmedic, Therapeutic Goods Administration, Team-NB, ANVISA, MDCG

Postscript 🐝

Please help us spread the word about MedTech Leading Voice. Share this issue with your colleagues.

Sean 🐝

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