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Pre-Submission Support: How a Testing Lab Can Help You Prepare for Regulatory Feedback
Pre-Submission Support: How a Testing Lab Can Help You Prepare for Regulatory Feedback Pre-submission is a critical phase in medical device development, especially under EU MDR. It’s the point where all your documentation — risk assessments, justifications, test...
How Early Should You Start Thinking About Biocompatibility in Product Development?
How Early Should You Start Thinking About Biocompatibility in Product Development? In the fast-paced world of medical device innovation, biocompatibility is sometimes treated as an afterthought — a regulatory hurdle addressed just before submission. However, this...
Why a Risk-Based Approach to Biocompatibility Saves You Time and Money
Why a Risk-Based Approach to Biocompatibility Saves You Time and Money In the realm of medical device development, ensuring biological safety is essential to protect patient health and to comply with regulatory requirements. However, the traditional approach of...
How to Create a Complete Biological Evaluation Report (BER) That Meets Regulatory Expectations
How to Create a Complete Biological Evaluation Report (BER) That Meets Regulatory Expectations A Biological Evaluation Report (BER) is a cornerstone document in the biological risk assessment process for medical devices. It integrates chemical characterization,...
What Happens If Your Medical Device Fails Biocompatibility Testing? Manufacturer’s Next Steps
What Happens If Your Medical Device Fails Biocompatibility Testing? Manufacturer’s Next Steps Biocompatibility testing is a critical step in medical device development, ensuring that the materials and components used do not cause adverse biological reactions in...
How to Document Biological Safety for Combination Products (Device + Drug)
How to Document Biological Safety for Combination Products (Device + Drug) Combination products, which incorporate both medical devices and pharmaceutical components, present unique regulatory challenges, particularly in biocompatibility and biological safety...
The Role of Material Selection in Successful Biocompatibility Outcomes
The Role of Material Selection in Successful Biocompatibility Outcomes Material selection plays a fundamental role in the biocompatibility of medical devices. Selecting the right materials increases the likelihood of a smooth and successful biocompatibility testing...
Time and Cost of Biocompatibility Testing: How to Plan Your Project Budget
Time and Cost of Biocompatibility Testing: How to Plan Your Project Budget Biocompatibility testing is a crucial step in the development of medical devices, ensuring compliance with regulatory requirements and safeguarding patient safety. However, testing can be both...
Regulatory Shifts: How MDR & FDA Updates Impact Biocompatibility of Medical Devices
Regulatory Shifts: How MDR & FDA Updates Impact Biocompatibility of Medical Devices IntroductionThe regulatory environment for medical devices is in a constant state of evolution. With recent updates from bodies such as the European Union’s Medical Device...
The Cost of Biocompatibility: How Medical Devices Labs Can Optimize Testing
The Cost of Biocompatibility: How Medical Devices Labs Can Optimize Testing IntroductionIn today’s competitive medical device market, ensuring biocompatibility is paramount. However, comprehensive testing can be expensive and time-consuming. Balancing rigorous safety...