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When Published Clinical Evidence Can Support an Expanded Intended Use: A Case Study
Expanding the intended use of a medical device does not always require a prospective clinical trial. In...
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Fit-for-purpose literature reviews: What type of literature review is right for your project?
A literature review (knowledge synthesis) summarizes available evidence on a specific question or topic. Reviews guide clinical...
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Real-World Data Are Everywhere. Useful Real-World Evidence Takes Planning
For many sponsors, real-world data can be both an opportunity and a risk. The right data source...
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From Published Clinical Evidence to Market Authorization
Expanding the intended use of a medical device in the United States is often assumed to require...
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Whitepaper Series: How MED Institute Accelerates Product Development – Insights into Each Core Capability
At MED Institute, we understand that selecting the right partner for medical device development is a critical...
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ISO 14155:2026 Changes
Introduction to ISO 14155 The International Organization for Standardization (ISO) develops independent, international standards in various sectors...
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FDA’s Partial Recognition of ISO 10993-1:2025 – What to Know and How to Prepare
FDA’s May 2026 partial recognition of the recently released ISO 10993-1:2025 standard has important implications for medical...
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Evaluating Genotoxicity under ISO 10993-1:2025 – Key Changes and Challenges
Genotoxicity refers to a material’s potential to damage genetic material (i.e., DNA) which is important because it...
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EU MDR Clinical Evaluation Technical Documentation
Overview For CE marking and throughout the device’s lifecycle, medical device manufacturers must demonstrate conformity with Regulation...
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Overcoming the Challenges of Biological Product Development in a Complex Regulatory and Economic Landscape
What are Biological Products? A biological product or “biologic” is a broad term for living material-derived larger...
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Leveraging Clinical Data to Support Reimbursement
Got data? Data from clinical studies, registries, and medical record review supports reimbursement pathways by demonstrating a...
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ISO 10993-1 Revision Highlights Part 4: Reinforcement of Material and Chemical Characterization
Read previous posts in this series Part 1, Part 2, and part 3. The importance of material...
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