Industry Perspectives - Design & Development

  1. 6 Essential Steps Of Forensic Medical Device Engineering 5/15/2024

    Forensic medical device engineering is investigating and analyzing medical devices that have malfunctioned, failed, or caused adverse events. Here are 6 steps to resolve issues.

  2. Stop Inspecting For Quality — Start Building It. 5/10/2024

    QC/QA activities that occur too late in the process or rely on a siloed team of inspectors can lead to significant waste and costs. Here’s the approach you should be using.

  3. A Critical Analysis Of FDA Human Factors IFU Guidance For Drug Delivery Devices 5/8/2024

    Drug administration by lay users is becoming more common. Is current FDA guidance viable for demonstrating safe and effective use for critical devices and systems? No.

  4. AI-Enabled Medical Devices In India: Opportunities And Challenges 5/7/2024

    India holds a lot of promise for the medical device sector. But can its regulations catch up with the with growing concerns about AI, security, and bias risks?

  5. Integrating Quality Processes And Documentation After A Merger 4/25/2024

    If your company is undergoing a merger, you must juggle operations while ensuring minimal disruptions. You'll need a holistic view of QMS and SOPs to harmonize procedures.

  6. Long Live Design Controls: Navigating The Shift From QSR To QMSR 4/22/2024

    The transition to a Quality Management System Regulation (QMSR) has effectively superseded the explicit medical device design controls CFRs and associated FDA guidance, though their essence lives on.

  7. A Holistic Approach To Your Medical Device's Usability 4/8/2024

    Medical device developers must plan and design for what happens once their device leaves the manufacturing facility. Consider how a device will make the journey to its intended users and how those users will work with the device.

  8. A Cost-Effective Approach To EU MDR Compliance 4/2/2024

    How can you be cost-effective in the face of the cost of compliance with the EU's Medical Device Regulation (MDR)? This article shares tips.

  9. 3 Ways The Agile Method Unlocks Rapid Innovation In Medtech 3/15/2024

    Scheduling daily team huddles, killing deadlines, and making space to reflect and grow are all agile teamwork elements that contribute to rapid innovation in medtech. Here's why.

  10. 6 Things Medtech Companies Should Know About The EU's AI Act 3/4/2024

    With the recent publication of the European Union’s long-awaited Artificial Intelligence Act (AI Act), the message to medtech companies is clear: you need to move toward compliance by understanding your AI systems, determining their role under the AI Act, and identifying the specific obligations and implementation strategies that apply.