Industry Perspectives - Design & Development

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. New FDA QMSR Through The Lens Of Risk Management: Requirements And Analysis 2/29/2024

    On Feb. 2, 2024, the FDA set a new cornerstone in the medical device regulatory landscape by releasing the new Quality Management System Regulation (QMSR), a forward step that is scheduled to be fully implemented by Feb. 2, 2026. Let's take a closer look, including the role of ISO 13485, expectations for compliance with ISO 14971, and more.

  6. Using Relational Risk Analysis To Control Procedure Failures 2/15/2024

    In the bio/pharma and medical device industries, operating procedures guide virtually every activity and are required for compliance with good manufacturing practices. Minimizing procedure execution failures is critical. To do so, you can use relational risk analysis (ReRA).

  7. Getting Out Of The Doldrums: Analyzing & Kickstarting Organizational Quality Maturity 2/8/2024

    It's difficult to consider what the impact of organizational culture might be on a quality system, its effectiveness and robustness, and even its maturity state. You need a way to spot when your team is in the doldrums and kickstart quality maturity. Regulators want it, so you should, too.

  8. 5 Focus Areas For Medtech Business Success In 2024 2/8/2024

    Medtech manufacturers able to manage today's uncertainty and change will seize on new opportunities through innovation. Successfully navigating this landscape requires proactive consideration of these 5 focus areas.

  9. Use-Related Risk Analysis For Combination Products 2/7/2024

    One of the most integral components in the development of drug-device combination products is the use-related risk analysis (URRA) and its applicability to the overall human factors engineering process. Deficiencies in the URRA are a leading cause of delays with FDA submissions.

  10. Foundational Human Factors Engineering Concepts For The Design Of Combination Products 2/5/2024

    How can companies keep pace with the demand in the combination products market while meeting or exceeding regulatory expectations of applying human factors engineering? This article provides an overview.