Hardware Podcasts

Navigating the Medical Device Single Audit Program (MDSAP)

Global Medical Device Podcast · 13 Apr 2022 · 40m · Episode 254

What this episode covers

Danny Kroo, a medical device consultant and sub-contract lead auditor for registrars like BSI, joins Jon Speer and Etienne Nichols of Greenlight Guru to explain the Medical Device Single Audit Program (MDSAP). Kroo details how MDSAP consolidates regulatory audits for the US, Canada, Japan, Brazil, and Australia, noting that while it simplifies global market access, it has raised costs and barriers for small companies. He emphasizes that the audit is highly prescriptive, relying on a 231-page FDA 'Audit Approach' document, and warns that companies with immature quality systems often struggle with specific requirements like change control and internal auditor qualifications.

Most relevant to

early-stage companies and companies scaling up

Topics

Mentioned

Companies
Greenlight Guru, BSI, Health Canada, FDA, DocuSys
Also
ISO 13485, EU MDR

Related episodes from other shows

Other shows on the same ground, closest first.

  • Let's Combinate · 13m

    215 - Why Aren’t Technical People Leading Drug-Device Audits?

    Subhi Saadeh, Founder of Let’s Combinate BioWorks, explains why engineers in pharma and medical devices should become auditors, arguing that technical expertise combined with audit methodology creates the most effective auditors. He details how auditing provides a system-level perspective, revealing how design decisions ripple through Quality Management Systems (QMS) and identifying systemic root causes that isolated engineering work often misses. Saadeh addresses common misconceptions, such as the view that auditing is merely bureaucratic paperwork, and reframes it as a critical tool for building regulatory fluency and career versatility across industries like aerospace and medical devices. He concludes with practical steps for engineers to enter the field, including shadowing internal audits, learning audit frameworks like ISO 13485, and seeking mentorship from experienced professionals.

    Quality & yieldCareers & education
    1 chapters

  • Let's Combinate · 1h 19m

    031 - "The Five Stages Of Regulatory Grief" with Michelle Lott

    Michelle Lott, founder of Lean RAQA, discusses her journey from large manufacturer Baxter Healthcare to consulting for small-to-mid-size medical device companies, highlighting the gap in practical regulatory strategy. She details the 'five stages of regulatory grief' clients experience when facing FDA interactions, contrasting the US 510(k) process with the rigorous, ongoing costs of EU MDR compliance. Lott also explains the nuances of regulations versus guidance documents, the QMSR harmonization, and her unique perspective as an elected industry representative on the FDA Device GMP Advisory Committee.

    Certification & complianceQuality & yield
    11 chapters

  • Let's Combinate · 32m

    130 - QMSR Changes to Traceability/Reporting, Independent Reviewer & Risk Management, Learning New Regulations and MDSAP with Aaron Snyder

    Aaron Snyder, VP of Quality Assurance at Allotex and AAMI Faculty member, explains the FDA's Quality Management System Regulation (QMSR) and its incorporation of ISO 13485. He details specific changes to traceability, including the requirement to meet 21 CFR Part 821 (Medical Device Tracking) and Part 830 (UDI) in addition to ISO requirements, and new FDA-specific controls for records, packaging, and labeling. Snyder contrasts FDA inspection techniques, which focus on finding non-compliance through deep dives into complaint and service records, with ISO surveillance audits that verify conformity. He also discusses the impact of QMSR on MDSAP companies, noting that while harmonization simplifies compliance for large firms, smaller US-only companies face more work to adopt the process approach and explicit risk management.

    Certification & complianceQuality & yield
    6 chapters

  • Let's Combinate · 13m

    168 - Audits, Audits, Audits: Why They Matter in Pharma, Medical Devices, and Personal Growth

    Subhi Saadeh, host of Let's Combinate and Quality Professional, discusses the parallel between Peter Drucker’s book 'Managing Oneself' and the role of audits in pharma and medical device industries. He explains the three levels of audits—first-party (internal), second-party (supplier), and third-party (regulatory/certification)—and their specific purposes in ensuring compliance with regulations like ISO 13485 and 21 CFR Part 4. Saadeh emphasizes that audits are systematic, evidence-based appraisal activities designed to reveal system weaknesses and build trust with regulators and patients, rather than just catching mistakes.

    Quality & yieldCertification & compliance
    1 chapters

  • Let's Combinate · 54m

    003 - “Standard Understanding” with Mark Swanson

    Mark Swanson, President of QRx Partners, discusses his extensive background in medical device quality, including his work on the ISO 13485:2016 revision and ISO 9001:2015 standards. He explains the consensus-driven process of writing international standards, highlighting the semantic challenges of terms like 'and/or' and the specific risk definitions in medical device regulations versus generic business standards. Swanson also details the practical implications of ISO 13485 certification for small to mid-sized companies, weighing the $30,000 annual cost against regulatory requirements and market access.

    Certification & complianceStarting a product company
    8 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.