How to Approach Verification and Validation for Cloud Software

Global Medical Device Podcast · 15 Apr 2020 · 39m · Episode 142

What this episode covers

John Spear, host of the Global Medical Device Podcast, interviews Brad Graves, Principal Project Manager at The RND Group, to clarify verification and validation (V&V) strategies for cloud-based medical device software. They distinguish verification (designing the product correctly) from validation (designing the correct product) and discuss how cloud architectures, such as containerization with Docker, allow for automated testing despite frequent vendor updates. The conversation highlights that while cloud software offers scalability and portability, it requires rigorous change management, including monitoring release notes and leveraging vendor-provided validation evidence to avoid redundant re-validation efforts.

Other shows on the same ground, closest first.

  • Let's Combinate · 44m

    090 - Software Validation, Automation, No-Code Quality Tools and QMS with Harsh Thakkar

    Harsh Thakkar, CEO of Qualtivate, explains how life sciences companies can automate quality management systems (QMS) using no-code tools like Zapier and Make to reduce manual reporting burdens. He details the regulatory framework for software validation, distinguishing between out-of-the-box, configured, and custom software categories defined in GAMP 5. Thakkar emphasizes that validation should focus on intended use and risk rather than validating the entire system, citing the FDA's Computer Software Assurance (CSA) guidance as a way to reduce documentation burdens.

  • IoT For All Podcast · 21m

    Software Validation and Testing in IoT | Doppelio's Gaurav Johri | Internet of Things Podcast

    Gaurav Johri, co-founder and CEO of Doppelio, explains why software validation is critical for connected products as value shifts from hardware to cloud and edge software. He details how Doppelio uses device virtualization to create 'Doppels' (digital twins) that allow enterprises to test at scale without physical devices, overcoming the limitations of custom simulators. Johri discusses the integration of physical and virtual labs, the role of intelligent automation in CI/CD pipelines, and the ROI of early defect detection in industries like automotive and medical devices.

  • The Pragmatic Embedded Podcast · 51m

    Version Control Techniques

    Jeff Gable and Luca engineer discuss version control strategies for complex embedded software, debating the merits of monorepos versus multi-repo architectures and the use of feature flags versus long-running branches for managing product variants. They emphasize the importance of continuous integration, automating build pipelines, and treating documentation and infrastructure as code to manage the inherent complexity of hardware-software coupling. The conversation also covers code review bottlenecks, advocating for pair programming and strict rules to prevent technical debt accumulation.

  • 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.

  • Being an Engineer · 43m

    Dakota Welker | User Needs, Design Inputs, Verification & Validation

    Dakota Welker, founder of Think MedTek, explains his four-phase product development methodology for medical device startups, emphasizing user needs, design inputs, verification, and validation. He details how he rescues stalled projects by clarifying scope and documentation, and describes a specific case where bringing manufacturing in-house and negotiating with multiple vendors reduced costs by 50%. Welker also discusses his transition from automotive and pneumatics to medical devices, his focus on CFD tools like Simscale, and the importance of balancing engineering rigor with client communication.

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.