Understanding Medical Device Verification and Validation When it comes to ensuring the safety and efficacy of medical devices, rigorous processes are in place to verify and validate their performance. This blog will delve into the world of Class II medical devices,...
Medical Device Testing
Medical Device Industry Trends to Watch
Medical Device Industry Trends for 2024 and Beyond The medical device industry is constantly evolving, driven by advancements in technology, changing healthcare needs, and a growing focus on patient-centric care. As we look ahead to 2024 and beyond, several key trends...
What to Look for in Medical Device Component Manufacturers
Quality Medical Devices Start with a Quality Manufacturer Medical device component manufacturers are the backbone of your Class II medical device operation. Whether it’s a life-saving implant, a diagnostic instrument, or a sophisticated monitoring device, the quality...
What is the Class II Medical Device Design and Development Process?
Innovation plays a pivotal role in enhancing patient care, diagnostics, and treatment outcomes. One critical aspect of this innovation is the design and development of Class II medical devices. This process involves a variety of stages, ensuring the final product...
Regulatory Development Indicates Shift Toward In Vitro
After several years of waiting, the International Organization for Standardization (ISO) approved the release of ISO 10993-23 in January 2021. The standard officially recognizes in vitro as an approved method for understanding, predicting and classifying skin...
What to Ask Before Submitting Your Medical Device for Approval
Testing your medical device properly and preparing a strong regulatory submission is a dynamic yet crucial part of bringing the product to the market. Put simply, the submission stage is not where most manufacturers want to gamble or guess. That’s where a qualified...
Packaging Pitfalls Medical Device Manufacturers Cannot Ignore
As stated in the international packaging standard, ISO 11607, designing and developing a packaging system for terminally sterilized medical devices is a complicated and critical endeavor. Even if manufacturers opt for a proven packaging configuration, it needs to...
Safe & Compliant: Mitigating Risks After Device Modifications
The medical device regulatory environment is continuously evolving. As regulatory body expectations become more demanding, manufacturers need to evaluate the safety implications of changes to their devices and processes. Manufacturing modifications are one example...
E/L Testing Isn’t What It Used to Be
Medical device biological safety evaluations have advanced significantly over the last ten years, and regulatory requirements are quickly evolving as well. Turnkey evaluation of testing requirements has progressed into a more device-specific evaluation of risks. It is...
3 Regulatory Red Flags with Medical Device Changes
Before modifying your medical device, consider how it could affect your testing plan and potentially put approvals at stake.
White Paper: Unknowns are Unacceptable™
Unknowns are Unacceptable explains our risk-based approach to medical device chemical characterization and toxicological risk assessment.