Guest Columns
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Navigating EU MDR Compliance: Overcoming Challenges To Sustain Your Certification
3/19/2024
This article dispels the myth that obtaining EU MDR certification is an end point. The evolving landscape demands ongoing diligence to comprehend and adhere to changing requirements.
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Best Practices Handling Material Changes For Medical Devices
3/18/2024
Despite the best intentions of procurement, suppliers may impose changes in the availability of material grades. Have a process for controlling and mitigating the effects of material changes in order to reduce risk and avoid interruption.
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2024 LIMS Trends
3/15/2024
The laboratory information management system (LIMS) landscape in 2024 is a dynamic one, driven by accelerating advancements in technology and evolving industry needs. This article shares the four key trends.
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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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A Structured Approach To Regulatory Information Management Vendor Selection
3/13/2024
Deploying a formal system for regulatory information management is a given now for all life sciences companies, irrespective of their size and focus. Regulators expect this, particularly as data rather than static documents evolves to become the default.
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Notable Public Comments On The FDA’s Proposed Regulation For Laboratory Developed Tests
3/12/2024
The proposed FDA regulation for laboratory developed tests marks a significant step toward the FDA trying to standardize oversight for these diagnostic tools. As the FDA seeks public input, it is a hot topic as stakeholders grapple with the implications of increased regulatory scrutiny, debating its impact on patient access, innovation, and the overall landscape of diagnostic testing in the U.S.
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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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Rapid Diagnostics And The Quest To Develop The Fabled Star Trek Tricorder
2/23/2024
Fans of Star Trek will recall the tricorder, the small gadget routinely carried by Dr. “Bones” McCoy. In the world of medtech and diagnostics, talk inevitably turns to the ongoing, yet elusive, search for such a multidisciplinary diagnostic device. This article shares efforts that have been made in recent years and some practical considerations.
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A Successful Technology Strategy for Medical Device Teams Asking, “Own Or Partner?”
2/16/2024
Rapid innovation in medtech is a breakthrough that scales. One way to move forward faster is to have the right technology strategy to decide what to do — and what not to do. A solid technology strategy gives you confidence in what to tackle yourself, what to partner on, and what to buy off the shelf.