Josh N
With over 11 years of experience in biocompatibility, Josh specializes in bridging the gap between CRO test laboratories and medical device manufacturers. He has successfully justified the biological safety of hundreds of medical devices, including instruments and implants in the orthopedic and cardiovascular sectors. As a subject matter expert, he has developed streamlined strategies for biological evaluation and ensured ongoing regulatory compliance. His expertise spans regulatory submissions across major markets, including the US FDA, EU MDR, and APAC regulatory bodies.
Our Expertise
Our team of subject matter experts cover your complete product life cycle needs across key geographies from preclinical discovery, product design and validation documentation, QMS regulatory affairs, clinical research, QMS/GMP and cybersecurity etc. We are here to accelerate your key countries market access with one-stop solution.
