Blog
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...
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...
A Guide to ISO 10993-18’s Analytical Evaluation Threshold
New identification standards are putting pressure on manufacturers' submissions. Make sure your sensitivity is up to regulations. Medical Device...
What’s the Future of Biocompatibility?
A risk-based approach that tailors test requirements to the specific risks of each device.
Streamlining Submissions with Product Adoption for Radiation Sterilization
Product adoption for radiation sterilization can cut costs and save time today and in the future.
6 MDR Facts to Not Lose Sight of
Despite the progress your company has made in preparing for the MDR, don’t overlook how these easy-to-miss factors affect your work.
WuXi AppTec Medical Device Testing Doubles Chemistry Capacity to Counteract MDR Pressures
To accommodate the high demand and help manufacturers meet the May 26, 2021 deadline, WuXi Medical Device Testing recently expanded its chemistry lab in Minnesota.
Stop Letting GLP Stunt Your Chemistry Studies
The FDA’s Good Laboratory Practice (GLP) regulations have led to some misconceptions for medical device manufacturers (MDMs). To better understand the misconceptions about when to apply GLP testing, I think it’s important to first look at what the FDA GLPs actually say: