Hardware Podcasts

Living Documentation and Test Automation with Paul Massey

The Pragmatic Embedded Podcast · 15 Jul 2021 · 52m

What this episode covers

Paul Massey, founder and CEO of Bluefruit Software, explains how to shorten release cycles for medical devices using living documentation and test automation. He discusses applying Agile principles to comply with standards like IEC 62304 and guidance document TIR 45, emphasizing the shift from efficiency to effectiveness. Massey details the use of Behavioral Driven Development (BDD) with Gherkin feature files to create executable specifications that serve as both tests and documentation, reducing the manual burden of compliance submissions.

Most relevant to

established companies

Topics

Mentioned

Companies
Bluefruit Software
Tools
Squish
Also
TIR 45, IEC 62304, Gherkin

Related episodes from other shows

Other shows on the same ground, closest first.

  • Global Medical Device Podcast · 55m

    #335: Accelerating SaMD Development in a Compliant Agile way

    Zach Markin, CEO, and Weronika Michaluk, Digital Health Principal at HTD Health, discuss accelerating Software as a Medical Device (SaMD) development through a methodology they call 'Compliant Agile.' They explain how HTD uses its 'SaMD Chassis' accelerator to handle common non-differentiating software functions, allowing clients to focus on novel clinical value while maintaining regulatory compliance. The guests detail their selection of Greenlight Guru as their Quality Management System (QMS) because it supports flexible, agile workflows and integrates with tools like Jira, helping them achieve ISO 13485 certification and reduce time-to-market.

    Connected products & IoTQuality & yield
    7 chapters

  • Global Medical Device Podcast · 25m

    Meet a Guru: Karen Schuyler

    Karen Schuyler, a Medical Device Guru at Greenlight Guru, discusses her 15-year career spanning product engineering at Gore, startup scaling, and quality strategy at large medical device companies. She highlights the industry's shift toward collaborative regulatory approaches and the challenges of adapting to frequent standard updates like ISO 13485 and EU MDR. Schuyler explains how Greenlight Guru’s software solves the inefficiency of manual traceability by automating linkages between design controls, risk management, and documentation, preventing the 'painting yourself into a corner' scenarios common in legacy systems.

    Validation & product-market fitQuality & yield
    5 chapters

  • Global Medical Device Podcast · 55m

    Leaning into Lean Documentation

    Steve Gompertz, a partner at QRX Partners with experience at St. Jude Medical, Boston Scientific, and Medtronic, explains the concept of lean documentation in medical device Quality Management Systems (QMS). He argues that documentation should be written for employees, not auditors, using hierarchical structures like flowcharts and appendices to improve usability. Gompertz details how to build effective Standard Operating Procedures (SOPs), manage CAPA execution, and prove the ROI of a well-architected QMS by reducing audit findings. He also outlines the essential early-stage components for a new medical device company, emphasizing design controls and management responsibility.

    Quality & yieldDesign for manufacturing & NPI
    8 chapters

  • Global Medical Device Podcast · 37m

    How to Leverage IEC 62304 to Improve SaMD Development Processes

    Cathy Wilburn, Director of Quality Assurance and Compliance at The RND Group, explains how to leverage the IEC 62304 standard for Software as a Medical Device (SaMD) development. She clarifies that IEC 62304 is a voluntary, recognized consensus standard that provides a framework for software lifecycle processes rather than a prescriptive waterfall methodology, allowing for agile integration. The discussion covers mapping these processes to FDA 21 CFR 820.30 design controls, using software safety classes (A, B, C) for risk management per ISO 14971, and navigating regulatory submissions for both the US (510(k)/PMA) and EU (MDR/IVDR).

    Certification & complianceEmbedded firmware
    5 chapters

  • Global Medical Device Podcast · 51m

    Digitizing your SaMD Testing

    Rahul Kallampunathil, Vice President of Arbour Group’s Digital Compliance practice, explains the regulatory and testing requirements for Software as a Medical Device (SaMD). He distinguishes SaMD from Software in a Medical Device (SiMD) and Medical Device Data Systems (MDDS), noting that SaMD requires a full regulatory pathway while MDDS is often Class I. Kallampunathil advocates for adopting agile and DevOps methodologies with automated testing to manage the rapid iteration cycles of SaMD, contrasting this with traditional Computer Software Validation (CSV) in favor of Computer Software Assurance (CSA). He emphasizes that quality management systems must be established before product design and that post-market surveillance, including cybersecurity and platform compatibility, is critical for SaMD success.

    Medical & health devicesQuality & yield
    7 chapters

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