Medical device biocompatibility evaluation is complex, and even experienced manufacturers can make costly mistakes that result in regulatory delays, additional testing requirements, and extended time-to-market. Understanding these common pitfalls can help you avoid them and streamline your path to approval. Based on extensive experience with regulatory submissions, here are the most frequent biocompatibility testing mistakes that cause approval delays—and how to prevent them.

Navigating the complex world of medical device biocompatibility can be overwhelming for manufacturers. With stringent regulatory...

Chemical characterization is   a term that encompasses the identification and analysis of extractable and leachable compounds that can...

Ensuring a device’s safety for human use demands meticulous planning and thorough analysis, particularly regarding biocompatibility. At...

Chemical characterization consulting services are a pivotal element in the development and approval of medical devices.

JL Tox Consulting can help you prepare a medical device biocompatibility safety evaluation to achieve regulatory success.

When it comes to manufacturing medical devices, ensuring safety and compliance is paramount. Navigating complex regulatory landscapes can...

Professional toxicological risk assessments are a cornerstone of ensuring the safety of medical devices.

Biocompatibility test plans are crucial to ensuring that medical devices are safe and compliant for patient use.

What exactly are chemical characterization consulting services, and why do you need them?

The regulatory landscape for medical devices is evolving rapidly, and ensuring compliance with the set regulatory standards is vital for...

Designing, manufacturing, and seeking registration for medical devices requires strict compliance with the set regulations. The...

Today, from diagnosis to management of diseases, in vitro diagnostics (IVDs) and medical devices play a significant role. To ensure the...

As it is with every other health product, the quality, safety, and efficacy of a medical device must be built into the product. Achieving...

Congratulations to NAMSA for being the first medical device CRO to receive FDA #ASCAAccreditation for Medical Device Biocompatibility...

One of the most unique aspects of medical device #biocompatibility is just how quickly your work can have a direct impact on patients....

Excited for this one by the Computational Toxicology Specialty Section of the Society of Toxicology (SOT). The applicability of the TTCs...

On June 7th, the U.S. FDA partially recognized ISO 10993-23:2021 Biological evaluation of medical devices - Part 23: Tests for irritation...

Michael Song, Ph.D., AstraZeneca, provides an overview of medical device biocompatibility. See the full article here:...

Contract research organization NAMSA announced its acquisition of Minneapolis-based American Preclinical Services (APS). Read more here:...