Guest Columns
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Colombia: A Strategic Choice For Medtech Clinical Trials
3/21/2024
Colombia, one of the top three economies and most populous countries in Latin America, is a promising destination for medical device clinical trials for these reasons.
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Process Development With “The End In Mind” For Startups
3/20/2024
We encounter the term “the end in mind” in product development frequently, but many are unsure what it really means and when it matters. This article sheds light.
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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.