Hardware Podcasts

Everything you Need to Know about SaMD from an FDA Perspective

Global Medical Device Podcast · 1 Mar 2021 · 46m · Episode 183

What this episode covers

David Pudwill, a former FDA official known as 'Mr. Regulatory', joins host Jon Speer to explain the regulatory landscape for Software as a Medical Device (SaMD). They define SaMD versus Software in a Medical Device (SiMD), discuss risk categorization based on intended use, and outline the FDA's Software Pre-certification Pilot Program. Pudwill advises developers to engage in early pre-submissions (Q-Subs) and utilize FDA guidance documents to navigate the path to clearance.

Most relevant to

early-stage companies

Topics

Mentioned

Companies
Greenlight Guru, FDA, IMDRF
Also
ISO 14971, Mr. Regulatory

Related episodes from other shows

Other shows on the same ground, closest first.

  • 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 · 41m

    134 - ISO62304, Software Development Process, SaMD, Closed Loop Systems, Complexities with Cloud and Better Software in MedTech with Richard Koch

    Richard Koch, founder of KochSaMD, explains the complexities of developing cloud-based medical devices, using a closed-loop insulin pump system as a primary case study. He details how ISO 62304 governs software development within the broader ISO 13485 framework, emphasizing the shift from batch-based physical manufacturing to continuous, high-velocity software updates. Koch warns that tech giants like Apple and Google are disrupting the industry by leveraging their digital expertise to acquire or compete with traditional medtech firms, urging leaders to upskill in software development to survive.

    Embedded firmwareConnected products & IoT
    7 chapters

  • Embedded.fm · 1h 09m

    67: Software for Things That Can Kill People

    Hosts Chris White and Elecia White discuss the rigorous regulatory processes for safety-critical software, drawing on their experiences with the FAA (DO-178B) and FDA (510k, PMA) for medical devices and avionics. They explain how hazard analysis determines certification levels, the necessity of extensive documentation and traceability, and the tension between agile development and waterfall compliance. The conversation highlights the ethical responsibility of engineers to push back against unsafe deadlines, the use of hardware compartmentalization (FPGAs, voting systems) to ensure safety, and the legal liabilities associated with product failures.

    Certification & complianceMechanical engineering
    8 chapters

  • Let's Combinate · 35m

    079 - How FDA Reviews Combination Products, Policy, EPR's, and Harmonization with Rumi Young

    Rumi Young, Director of Regulatory Policy at Becton Dickinson (BD), explains how the FDA reviews combination products, drawing on her previous tenure as Acting Assistant Director in CDRH’s Division of Drug Delivery. She details the inter-center consult process for products like auto-injectors and smart connected devices, highlighting the manual nature of current submissions and the critical need for clear device identification in NDAs and BLAs. Young discusses the role of industry in shaping policy, advocating for updated Essential Performance Requirements (EPRs) and international harmonization through IMDRF to address the gap between evolving technologies and outdated guidances.

    Connected products & IoTCertification & compliance
    8 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

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.