Blog
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...
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...
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...
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...