Guest Columns

  1. Spanish Is Not One Regulatory Language 9/4/2026

    Medical device manufacturers with regulatory plans in Latin America often treat translation as a procurement task. But is the translated document usable by the regulator and other key entities in the country in question?

  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. Implementing And Optimizing Your eQMS 8/25/2026

    This article addresses everything that follows the signed contract for an eQMS: how a system is configured, validated, adopted, and maintained.

  4. 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.

  5. CSV Assumes The AI System Sits Still — It Doesn't. 8/17/2026

    The computer system validation playbook was written for software that holds its shape. AI doesn't. Validating it has to become an act of governance.

  6. Medical Device Licensing Timelines In India To Shorten Under Proposed Amendments 8/3/2026

    India’s Ministry of Health and Family Welfare has proposed amendments to the Medical Devices Rules 2017 that will shorten manufacturing license timelines while preserving quality, safety, and performance requirements.

  7. When ANVISA's Clock Runs Out 7/30/2026

    In June, Brazil's ANVISA released a batch of clinical trial petitions because its review deadline had expired without a decision. Take a closer look at what medical device companies should know.

  8. Microneedles In Drug Delivery: From Bench To Patch 7/10/2026

    Let's take a closer look at the scientific principles, technological progress, and translational hurdles defining the present state of microneedle research.

  9. 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.

  10. 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.