Hardware Podcasts

248 - What Is a Quality Unit? QA vs. QC Explained

Let's Combinate · 29 Jul 2026 · 8m

What this episode covers

Subhi Saadeh, a quality consultant specializing in drug-device combination products, explains the regulatory and practical distinctions between the Quality Unit, Quality Assurance (QA), and Quality Control (QC). He defines the Quality Unit as the overarching function responsible for establishing, operating, and releasing products within a quality management system. Saadeh details how QA focuses on system processes like audits and change control, while QC focuses on tangible testing and inspection, noting that organizational structures vary significantly between pharmaceutical and medical device companies.

Most relevant to

established companies

Topics

Mentioned

Also
21 CFR 211, ICH Q10

Related episodes from other shows

Other shows on the same ground, closest first.

  • Global Medical Device Podcast · 38m

    #380: Navigating the Complex World of Combination Products with Subhi Saadeh

    Subhi Saadeh, host of the Combinate Podcast and expert in combination products, discusses the regulatory complexities of integrating drugs, devices, and biologics, including the differences between US FDA and EU regulatory pathways. He explains the definitions of single entity, co-packaged, and cross-labeled products, and addresses common misconceptions about the differences between drug and device quality systems. Saadeh also shares his journey of starting the podcast to maintain consistent learning and production, highlighting the importance of lifelong learning and leveraging coaching to balance technical and business aspects of the MedTech industry.

    Medical & health devicesCertification & compliance
    8 chapters

  • Global Medical Device Podcast · 54m

    #329 The Right Way to Start a QMS: When, How, & What

    Rob MacCuspie, Manager of Regulatory and Quality Affairs at Proxima Clinical Research, explains how to build a Quality Management System (QMS) by balancing investor cost concerns with FDA regulatory requirements. He argues that a QMS is not just a document management system but a culture driven by management responsibility and people, using a 'highway vs. mountain road' analogy to describe risk-based rigor for different device classes. MacCuspie details the phased implementation of QMS components, the specific challenges of Software as a Medical Device (SaMD) regarding labeling and testing, and the operational efficiency gains of moving from paper to compliant electronic systems like Greenlight Guru.

    Quality & yieldCertification & compliance
    9 chapters

  • Global Medical Device Podcast · 39m

    #420: MedTech Synergy: The Project Manager and Quality Professional Relationship

    Beth Waring, a medical device consultant at Greenlight Guru, discusses the critical relationship between project managers and quality professionals, advocating for a shift from a 'police force' mentality to a collaborative partnership. She explains the distinction between 'big Q' (the department) and 'small Q' (a company-wide quality mindset), emphasizing that open communication and explaining the 'why' behind procedures are key to adoption. The conversation highlights how digital EQMS solutions like Greenlight Guru streamline design controls, change orders, and traceability, reducing the manual burden on project managers and ensuring compliance with regulations like 21 CFR Part 820 and ISO 13485.

    Quality & yieldDesign for manufacturing & NPI
    9 chapters

  • Global Medical Device Podcast · 38m

    Meet a Guru: Erica Loring

    Erica Loring, a medical device guru at Greenlight Guru, discusses her background in pharmaceuticals and IVDs, emphasizing the critical distinction between Quality Assurance and Regulatory Affairs. She explains how the 'throw it over the wall' mentality creates documentation gaps and costly remediation, advocating for cross-functional collaboration from concept to market. Loring highlights the importance of investing in people, allowing adequate time for development, and rigorously auditing suppliers to ensure successful product launches.

    Quality & yieldCertification & compliance
    7 chapters

  • Global Medical Device Podcast · 42m

    What are the Opportunities for Improvement (OFI) for Quality?

    Jon Speer, founder of Greenlight Guru, hosts Mike Drues of Vascular Sciences to discuss the definition and implementation of quality in the medical device industry. They argue that regulatory quality is about consistency rather than subjective 'good or bad' outcomes, and that quality management systems should serve as a business philosophy rather than just a compliance checklist. The conversation highlights the disconnect between product design validation and manufacturing process validation, especially in Class 1 and 2 devices.

    Quality & yieldDesign for manufacturing & NPI
    8 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.