Industry Perspectives - Design & Development

  1. The Career Path Through QA Produces Better Medtech Engineering Leaders 9/9/2026

    Engineers with direct exposure to failure outcomes are more likely to build risk mitigation in from the start, not bolt it on later. When they're tapped for leadership positions, this makes them better leaders.

  2. Navigating The New Era Of Design Controls For SaMDs: A Strategic Guide 8/31/2026

    This article explores the current state of design controls for software as a medical devices (SaMDs), focusing on the FDA’s recent regulatory shifts, the integration of Agile methodologies, and the evolving landscape of AI/ML.

  3. A Much-Improved Approach For Understanding And Managing Safety Risks 8/18/2026

    Learn how causal mechanism and effect analysis (CMEA) and its principles can be used to develop and maintain safer working environments in the pharma/biotech and medical device industries.

  4. Are Document Approvals Consistent Across Sites And Appropriate? 7/9/2026

    Medical device document approvals seem to be a roadblock when you are the most pressed for time. But if the right approvers and document owners are defined appropriately, approval can be streamlined.

  5. Analyzing And Managing CDMO Project Risks Using Causal Mechanism & Effect Analysis 7/8/2026

    Since every sponsor–CDMO relationship can have widely different scopes, requirements, and procedures, this article focuses on the basic principles for analyzing and managing the risks of not achieving the relationship’s objectives.

  6. Improving Execution Of Biological Evaluation Of Drug Delivery Devices 6/3/2026

    This article provides a framework to streamline the biological safety assessment process, reduce testing burdens, and improve patient safety for combination products.

  7. Risk Is the Spine: What The First 100 QMSR Inspections Reveal 5/29/2026

    The FDA has now completed just over 100 inspections under its new Quality Management System Regulation, and the agency has begun sharing preliminary observations from those inspections.

  8. Rethinking CQV In A Digital, Agile Manufacturing Landscape 5/21/2026

    While commissioning, qualification, and validation (CQV) remains foundational, the way it is planned and executed must evolve to keep pace with modern manufacturing realities.

  9. Causal Mechanism And Effect Analysis (CMEA): FMEA's Simpler, Effective Alternative 5/1/2026

    This article describes causal mechanism and effect analysis (CMEA) as an alternative to failure mode and effect analysis (FMEA) for analyzing and managing the industry’s risks.

  10. Selecting The Right eQMS To Maximize Quality Maturity 4/23/2026

    Let's take a closer look at the current electronic quality management system (eQMS) landscape in pharma/biotech and what a future-ready eQMS must enable to support continuous improvement.