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The transition to a Quality Management System Regulation (QMSR) has effectively superseded the explicit medical device design controls CFRs and associated FDA guidance, though their essence lives on.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