Regulatory & Compliance Perspectives
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FDA Warns Industry Of Fraudulent & Unreliable Lab Testing Data In Premarket Submissions
4/11/2024
The FDA recently announced that they have seen an increase in the number of entities that contract out testing or services where the data provided by said firms was fabricated, duplicated, or just deemed “unreliable.” Here's what you can do.
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Will Argentina Be The Next Medtech Clinical Trial Destination In Latin America?
4/10/2024
With a population surpassing 44 million, Argentina presents a compelling proposition for medtech clinical trials, bolstered by its robust healthcare system, modern facilities, and experienced medical professionals.
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Understanding The New MHRA Requirements For Medical Devices In Great Britain
4/9/2024
The U.K.’s MHRA has updated its transition arrangement dates for CE marked devices with regard to EU MDR compliance.
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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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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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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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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.