Blog
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 Medical Device Planning Meetings as a Step Toward Regulatory Approval
The current regulatory environment has created both opportunities and setbacks for medical device companies as they work toward obtaining regulatory approval...
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...
Responding to Regulatory Requests for Additional Information
There's been a significant increase in the prevalence of requests for additional information in recent months, particularly following ISO 10993-18:2020....
Developing Cleaning Methods for Successful Validation
When it comes to reusable devices, one of the many requirements in medical device development is providing detailed directions of the cleaning methods defined...
TRA of Medical Devices & Proposed Updates to 10993-17
In cases where biocompatibility testing may not entirely mitigate medical device risk, chemical characterization data has become increasingly important. The...
Webinar: Biocompatibility Evaluation of Medical Devices for Global Registration
When preparing your medical device for a global submission, there are many factors to consider from developing a testing plan to keeping up with regulatory...
Extraction Techniques: Designing the Right Studies to Get the Answers You Need
Having a clear understanding of the chemistry required for regulatory submission is not an easy feat. Chemistry background knowledge is crucial when making...