Animesh Agrawal Email & Phone Number

As an accomplished R&D Manager with over a decade of experience in Medical Device Product Development, I have dedicated my career to advancing healthcare solutions through innovative technology. My expertise spans the entire product lifecycle, from initial design and development planning to verification and validation, clinical evaluation, and design transfer. I have a proven track record of obtaining regulatory clearances, including USFDA-510(k), CE marking (MDD/MDR), and Indian MDR for class II and III medical devices, ensuring that products meet stringent safety and efficacy standards.In my current role as Principal Engineer – PLM at Axio BioSolutions Pvt Ltd, I lead the R&D and Product Development department, overseeing multiple projects from concept to commercialization. My experience includes managing new product development, conducting preclinical and performance studies, and preparing comprehensive technical documentation for regulatory submissions, ensuring a seamless transition from development to market.I have been passionate about fostering cross-functional collaboration and establishing strategic partnerships with vendors and external stakeholders. My work developing advanced biomaterials and tissue engineering solutions has resulted in multiple patents and numerous scientific publications. With a strong foundation in biomedical engineering and biotechnology, complemented by an executive MBA, I am committed to driving innovation in the medical device industry and impacting patient care globally.Medical device innovator | USFDA-510(k) & CE Mark | Specializing in wound care solutions | Pre-clinical studies and regulatory documentation | Committed to driving healthcare advancements

Listed skills include Biomaterials, Scanning Electron Microscopy, Polymers, Uv/Vis, and 30 others.