Before modifying your medical device, consider how it could affect your testing plan and potentially put approvals at stake.
Medical Device Testing
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 development timelines for new products and, in some cases, can influence which products a company can keep on...
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 time. In a recent article for MedTech Intelligence, WuXi AppTec Principal Scientist Dan Fowler dives into...
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 on can affect the entire process, so it is critical to think long-term and prioritize quality to avoid...
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 affecting testing labs. Previous industry projected timelines and costs are becoming less feasible with today's...
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 limitations of biocompatibility testing. While the data it can provide still have a pivotal role in the assessment...
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 standards of regional regulatory organizations adds to the chaos. But when you know the different interpretations...
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. Collaborating on these responses is the best way to deliver quality answers promptly, and WuXi AppTec Medical...
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 in the Instructions for Use (IFU). Validating those cleaning methods may seem to be a box to check before...
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 updates to ISO 10993-18:2020 are applying pressure to supply sufficient chemistry data, meaning the industry...
White Paper: Unknowns are Unacceptable™
Unknowns are Unacceptable explains our risk-based approach to medical device chemical characterization and toxicological risk assessment.
