Hardware Podcasts

249 - The Best Audit Advice Nobody Told Me

Let's Combinate · 5 Aug 2026 · 14m

What this episode covers

Subhi Saadeh, a quality professional and certified lead auditor specializing in drug-device combination products, shares five key lessons learned from transitioning from the auditee to the auditor side. He emphasizes that audits should evaluate the health and adequacy of a system rather than targeting individuals, and that auditors must look for systemic patterns rather than isolated errors. Saadeh also stresses the importance of setting realistic scopes, recognizing auditing as a distinct skill set separate from technical expertise, and lowering anxiety to gather better evidence.

Most relevant to

established companies

Topics

Mentioned

Also
PDA

Related episodes from other shows

Other shows on the same ground, closest first.

  • Global Medical Device Podcast · 41m

    Auditing the Auditor

    Sara Adams, a Medical Device Guru at Greenlight Guru, explains the nuances of conducting and receiving audits, distinguishing between internal, supplier, notified body, and FDA inspections. She shares her experience managing approximately 25 audits annually at a previous contract manufacturing role and details how to negotiate findings by asking auditors to cite specific regulations. Adams emphasizes building a culture of quality where audits are viewed as opportunities for improvement rather than punitive checks, warning against treating quality management systems as static 'checkbox' exercises.

    Quality & yieldCertification & compliance
    9 chapters

  • Global Medical Device Podcast · 33m

    For the Love of Internal Auditing

    Jon Speer, founder of Greenlight Guru, interviews Sara Adams, a medical device guru at Greenlight Guru, about the strategic value of internal auditing in medical device quality systems. They discuss shifting from checkbox compliance to risk-based auditing, debunking misconceptions that every finding requires a CAPA or that all processes must be audited annually. The conversation highlights the importance of planning, cross-functional collaboration, and using electronic QMS platforms like Greenlight Guru to streamline audits and improve regulatory readiness.

    Quality & yieldCertification & compliance
    8 chapters

  • Global Medical Device Podcast · 36m

    What are the Audit Etiquette Rules I Should be Following?

    Greenlight Guru founder Jon Speer interviews Taylor Brown, a certified ISO 13485 Lead Auditor and medical device guru at Greenlight Guru, on the rules of audit etiquette. Brown explains that maintaining a 'stay ready' culture, where the Quality Management System (QMS) is the daily way of life rather than a panic-driven response, is critical for passing audits. The conversation covers specific behaviors such as controlling information flow, leveraging internal audits, and using the Greenlight Guru software to facilitate efficient, evidence-based audits.

    Quality & yieldCertification & compliance
    10 chapters

  • Global Medical Device Podcast · 27m

    Past, Present, Future State (and World) of Quality in the Medical Device Industry

    Mark Alpert, Director of Quality at Greenlight Guru, discusses the current state of quality in the medical device industry with host Jon Speer. Alpert argues that complexity in quality systems guarantees mistakes and that companies have lost their way by focusing on compliance rather than continuous improvement. He advocates for a 'do versus don't do' mindset during audits to preserve creativity and simplify processes, noting that the industry is currently struggling with the transition to EU MDR and IVDR regulations.

    Quality & yieldCertification & compliance
    8 chapters

  • Global Medical Device Podcast · 39m

    #367: Interviewing the Interviewer

    Etienne Nichols, host of the Global Medical Device Podcast at Greenlight Guru, is interviewed by Devon Campbell of Prodct LLC to reflect on lessons from nearly 100 episodes. Nichols discusses the importance of vulnerability in project management, the critical role of human factors and usability in medical device design, and the need to simplify Quality Management Systems (QMS) to benefit operations rather than just passing audits. He emphasizes a networking mantra of 'learn, lead, and love' and advises emerging entrepreneurs to own their expertise and actively influence regulatory pathways.

    Validation & product-market fitQuality & yield
    6 chapters

The summary, chapters and topics are generated from the episode’s audio by this directory, not written by Let's Combinate. The episode itself belongs to its publisher.