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...
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,...
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...
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,...
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...
New identification standards are putting pressure on manufacturers' submissions. Make sure your sensitivity is up to regulations. Medical Device Regulation (MDR) and recent International Organization for Standardization (ISO) revisions emphasize the importance...
A risk-based approach that tailors test requirements to the specific risks of each device.
Product adoption for radiation sterilization can cut costs and save time today and in the future.
Despite the progress your company has made in preparing for the MDR, don’t overlook how these easy-to-miss factors affect your work.
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.
Unknowns are Unacceptable explains our risk-based approach to medical device chemical characterization and toxicological risk assessment.
