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...
Medical Device Testing
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...
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 decisions regarding study design and preparing a device for submission. With this insight, you can gain more...
AATCC TM 100-2019: Assessment of & What It Means for Medical Textiles
Staying up to date on regulatory requirements and industry standards can be a challenge with ever-evolving expectations. However, keeping a close eye on changes in standards will insure that your medical device testing stays on track to a successful submission. Today,...
Maximizing Your Lab Partnership: Details Pay Dividends
Have you ever wondered “why do labs ask for so much information?” Or “how can we speed up this testing process?” Those two questions actually have a lot to do with each other. The devil is in the detail. Labs need to ask a lot of questions about your device to be able...
5 Questions You Need To Ask Your Testing Partner
If your organization is planning for a submission under the Medical Device Regulation (MDR), it’s important to consider outsourcing your testing needs to a testing lab. Working with an experienced partner that is well-versed in the latest standards can save you time,...
The Secret Recipe for Testing Success
Every great chef has a secret “something” to their name – a recipe, a technique, an ingredient. It stands to reason that a lab largely concerned with chemistry would also have its own special something. After all, cooking is a form of chemistry, isn’t it? While some...
White Paper: Unknowns are Unacceptable™
Unknowns are Unacceptable explains our risk-based approach to medical device chemical characterization and toxicological risk assessment.