Global Medical Device Podcast · 29 Jun 2026 · 38m · Episode 462
Michaela Kivett, a medical device consultant at Greenlight Guru, explains the strategic implementation of an electronic Quality Management System (eQMS) using a 'moving house' analogy to warn against simply migrating messy legacy data. She details the operational friction of paper-based or generic repository systems like SharePoint, highlighting issues with version control, physical signatures, and tracking personnel across large facilities. The conversation emphasizes leveraging AI to scan documents for ISO 13485 compliance gaps and automating workflow updates to mitigate the efficiency dip during transition. Kivett argues that successful adoption requires a culture of quality and a structured, room-by-room self-evaluation of procedures rather than just installing new software.
Where this conversation describes AI being used to build or deliver a product. Part of the AI in practice tracker.
Running the company
AI scans documents to find potential deficiencies against ISO 13485 standards, enabling a self-audit of documentation and identifying problem areas.
“there's there's plenty you can do with AI to help you scan through your documents and find potential deficiencies with ISO 1345. That's an, that's an easy way to, to do a self-audit of your documentation, have it spit back some problem areas for you.”
Speaker 1 · Hear it at 27:55
Running the company
AI reads through titles of records in a single folder to suggest logical categories for organization, such as grouping 1,000 documents into three distinct sets.
“Even then you could just simply pull an ISO 1345 audit prep, table, and and kickstart your review that way, you absolutely don't have to start from scratch. So AI is a great tool. And even just having it, you know, suggest categories of documents. If you have all of your records in one single folder. If you have a 1000 of it can read through the title and say, okay, these are the 3 groups you need to create.”
Speaker 1 · Hear it at 27:55
early-stage companies and companies scaling up
Other shows on the same ground, closest first.
Larry Mager, Founder of MGMT-CTRL, explains why fewer than 20% of companies have started Quality 4.0 despite 63% believing it will transform operations. He introduces his Quantum Quality Management (QQM) framework, a five-phase roadmap that prioritizes people, process, and technology to move beyond compliance. Mager argues that legacy Electronic Quality Management Systems (EQMS) fail because they are pre-programmed, whereas modern solutions use 'digital twins' to model workflows and ensure digital continuity. He emphasizes that successful implementation requires a strategic roadmap, cultural change, and management control rather than just installing software.
Jon Speer, founder of Greenlight Guru, explains how his frustration with managing medical device quality via Excel spreadsheets led to the creation of a dedicated QMS software platform. He details the transition from chemical engineering to medical device systems, highlighting the specific pain points of manual data merging and the high validation burden for electronic records. The episode covers Greenlight Guru’s development, its focus on design controls and traceability matrices, and the regulatory challenges of FDA submissions and ISO 13485 certification for startups.
Naveen Poonian, President and CEO of iBase-T, discusses the critical state of quality management in aerospace and defense manufacturing, citing Boeing and Starliner delays as examples of risks when speed compromises quality. He argues that manual, paper-based processes and disconnected data systems lead to massive rework costs and quality escapes, urging a shift to digital ecosystems that enforce process control. Poonian highlights the urgent need to capture retiring workforce tribal knowledge into software to prevent quality loss and enable hyper-automation. He outlines iBase-T’s consultative approach to implementing MES and MRO solutions, emphasizing cloud-native agility, IT/OT integration, and phased adoption strategies to ensure user buy-in and successful digital transformation.
Andrew Steele, founder of FactoryQA, discusses the critical role of quality management systems (QMS) in manufacturing, emphasizing that quality must be a cultural element driven by engaged employees rather than just a posted policy. He explains how ISO 9001 certification serves as a vital credibility signal for suppliers and outlines the significant risks of poor quality, including high costs of poor quality and reputational damage. Steele highlights the inefficiencies of analog, paper-based systems and introduces FactoryQA as a cloud-based solution that digitizes non-conformance tracking, document control, and inspection sheets to enable real-time analytics and predictive maintenance.
Vin Cafiso, former FDA Consumer Safety Officer and Managing Consultant at Practical Compliance Results, discusses the transition from the Quality System Regulation (QSR) to the Quality Management System Regulation (QMSR) and its impact on small medical device companies. He explains how FDA inspection methodologies are shifting from issue-focused 483s to process-based QSET audits, emphasizing the importance of understanding quality culture through simple engagement rather than rigid metrics. Cafiso shares insights from his career at companies like BD and Smith & Nephew, highlighting how starting as an investigator builds a strong foundation for industry roles by providing a broad view of quality systems across diverse products and company sizes.
The summary, chapters and topics are generated from the episode’s audio by this directory, not written by Global Medical Device Podcast. The episode itself belongs to its publisher.