Blog
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...
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...
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...
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....
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.
Planning and Predicting for ISO 10993: Part 18 & Part 17
Regulations published by the International Standards Organization (ISO) provide a global structure for the medical device industry. These standards can affect...
In the News: Readying Reprocessed Devices
Writing cleaning instructions for reprocessed medical devices can pose unique challenges during IFU development, but it is critical to get it right the first...
Preparing for a Pre-Submission Meeting En Route to Regulatory Approval
The current regulatory environment has created opportunities and setbacks for medical device companies as they work toward obtaining regulatory approval on...
Don’t Let Unknowns Threaten Your Toxicological Risk Assessment
As regulatory expectations intensify, medical device testing can require more time and budget to satisfy standards. The testing plan decisions you make early...
Behind the Curtain: How ISO 10993 Impacts Testing Labs
Manufacturers are not the only ones facing challenges due to the updates to ISO 10993 and other recent regulatory changes. The evolving standards are also...
The Evolving Outlook on Toxicological Risk Assessments
Around the world, various regulatory factors are driving the evolution of medical device risk evaluation. The industry is beginning to recognize the...
Preparing Biocompatibility Risk Assessments for International Registration
With many factors to consider, preparing a global submission may seem daunting, and adhering to the varying testing requirements and interpretations of...