In’Tech Medical SAS (https://www.intech-medical.com), the leader in contract manufacturing of orthopedic medical devices, today announced the creation of a Global Regulatory Affairs Department, to support Medical Device companies across its facilities.
The reality in the Medical Device industry is that the regulatory element to any Medtech organization is more important than Research & Development, Manufacturing or Sales & Marketing. For a company to contemplate a successful expansion, regulatory affairs conversations and decisions must take place at each stage of the device’s life cycle, ensuring patient safety.
This is true around the world, and Europe is leading the way right now with the new Medical Device Regulation (EU-MDR), causing major disruptions to the regulatory obligations of Original Equipment Manufacturers (OEMs), importers and distributors involved in the medical device distribution chain.
In’Tech Global Regulatory Affairs initiative is precisely designed to help OEMs solve the problem by offering regulatory support as well as a portfolio of turnkey approved products.
“In the past 20 years, In’Tech has constantly innovated in response to market conditions and customer needs,” said Laurent Pruvost, President & CEO of In'Tech Medical. “This global regulatory initiative we are launching continues in that tradition, supporting each of our facilities in USA, France & Malaysia, while focusing on providing customers with all the tools & data to support their product launch. I like to say that we are not in business to sell instruments, but to provide solutions to complicated MedTech conditions. The regulatory environment is definitely becoming more and more complex to navigate, and we are proud to offer solutions setting up our customers for success, thus further improving patient care.”
Thanks to a strong quality & regulatory background, Tania Shammo will lead the initiative as In’Tech’s new Global Regulatory Affairs & Quality Assurance Director. She comes to the position with over two decades of RA/QA experience both in the United States and Internationally, with organizations such as Bradshaw Medical in the US and Leader Biomedical in the Netherlands.
"Tania possesses deep regulatory expertise and has a proven track-record at managing quality assurance and regulatory affairs programs internationally," said Xavier Leroy, In’Tech’s Chief Operating Officer. "In addition to helping the In’Tech Group build rock-solid quality and regulatory foundations, I am confident that her department will also become a key ingredient to many of our customers’ regulatory strategy as they expand.”
You may catch up with In’Tech Team later this week at COA (China Orthopedic Association) in Shanghai, China, November 14-17, booth #8-1J06, Hall 8.2 (ORTHO-Processes Pavilion).
About In’Tech Medical
The In’Tech Group is a global leading contract manufacturer of surgical instruments, implants, cases & trays and silicone handles. Powered by 800 employees across the globe, In’Tech is a premiere engineering powerhouse, capable of delivering manufacturing solutions anywhere, at any time. As a healthcare technology innovator, In'Tech is renowned for its portfolio of turnkey designs as well as Wayvio® data-driven asset management solution.