Hardware Podcasts

#460: FDA AI Regulations: Master the QA/RA Skills to Stay Ahead

Global Medical Device Podcast · 18 May 2026 · 15m · Episode 460

What this episode covers

Etsy Nichols discusses the evolving FDA regulatory landscape for AI-enabled medical devices, highlighting the establishment of the Digital Health Center of Excellence and the shift toward rigorous documentation over algorithmic sophistication. She outlines five guiding principles for AI/ML-based Software as a Medical Device (SaMD) and emphasizes the critical importance of Predetermined Change Control Plans (PCCPs) in bridging US and EU regulatory requirements. Nichols argues that QA/RA professionals must combine regulatory fluency with AI literacy to navigate these complex systems effectively.

Most relevant to

early-stage companies

Topics

Mentioned

Companies
Piralia
Also
FDA, Digital Health Center of Excellence, EU AI Act, EU MDR, PCCP, IMDRF

Related episodes from other shows

Other shows on the same ground, closest first.

  • Being an Engineer · 51m

    S5E29 Steve Gompertz | Medical Device Quality Control & Regulatory Requirements

    Steve Gompertz, a partner at QRx Partners with prior leadership roles at Medtronic, Boston Scientific, St. Jude Medical, and Pelican Biothermal, explains how to build scalable quality management systems for medical device companies. He details the evolution of regulatory frameworks, noting the shift toward stricter EU standards and the integration of AI and cybersecurity into device compliance. Gompertz emphasizes tailoring quality systems to company size, using a case study of a client who reduced FDA findings from dozens to zero by implementing a holistic, process-connected system rather than a checklist approach. He also advocates for concurrent engineering and cross-functional teams to accelerate development while maintaining rigorous safety standards.

    Medical & health devicesQuality & yield
    10 chapters

  • Let's Combinate · 32m

    107 - Distilling Decades of MedTech Data, Generative AI, and Doing Without Tribal Knowledge with Michelle Wu

    Michelle Wu, CEO and Founder of NyquistData, explains how her company uses generative AI to distill decades of MedTech data, removing the 'tribal knowledge' barrier for quality and regulatory professionals. She details the distinction between pre-trained models and fine-tuned algorithms, emphasizing that Nyquist’s data is validated and specific to FDA and global medical device regulations, unlike generic models like OpenAI. Wu discusses the challenge of changing organizational culture and overcoming skepticism in life sciences, highlighting features like the 'Device Explorer' and 'Data Writer' that democratize access to complex regulatory insights.

    AI & machine learningQuality & yield
    10 chapters

  • Let's Combinate · 9m

    256 - The New FDA Inspection Playbook: Where to Start with QMSR

    Subhi Saadeh, founder of Let’s Combinate, introduces a four-part series on FDA inspection readiness under the new Quality Management System Regulation (QMSR), explaining how the retired QSIT framework has been replaced by Compliance Program 7382.850. He highlights advice from former FDA investigator Eric Pittman, who advises industry to focus exclusively on Section III of compliance programs as the primary roadmap for inspections. The episode details the shift from QSIT’s four major subsystems to six QMS areas, emphasizing a risk-based approach where investigators evaluate product risks and control effectiveness.

    Certification & compliance
    3 chapters

  • Let's Combinate · 1h 03m

    021 - "Options" with Karandeep Singh Badwal

    Karandeep Singh Badwal, a QA/RA consultant and host of The MedTech Podcast, explains how defining 'intended use' determines whether a product is a regulated medical device or unregulated software, a critical distinction for startups. He details the specific regulatory challenges of Software as a Medical Device (SaMD), including cybersecurity, GDPR compliance, and the impact of the EU MDR on software classification. Badwal also discusses the strategic advantages for UK software companies post-Brexit, where they can still self-certify as Class 1 devices while EU counterparts face stricter notified body audits.

    Validation & product-market fitQuality & yield
    9 chapters

  • Let's Combinate · 34m

    172 - Regulatory AI Innovations, Drugs@FDA Database, Regulatory Intelligence Strategies, Human Factors Insights, and Smarter Submission Approaches with Doug Mead

    Doug Mead, founder of CP Pathways and Rhizome AI, explains how his company uses AI to search the FDA's Drugs@FDA database, enabling faster regulatory intelligence for combination products. He details the transition from manual Google searches to a specialized tool that handles OCR and semantic search to interpret review memos, human factors data, and Type C meeting minutes. Mead highlights the value of understanding FDA precedents for products like auto-injectors and on-body injectors, while noting limitations such as redacted data and unpublished supplement reviews.

    Connected products & IoTCertification & compliance
    7 chapters

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.