Vivek Singh is a highly accomplished expert in Medical Device Regulatory Affairs and Quality Management, bringing over 15 years of experience in the medical device industry. As the founder and director of Tacit Medtek Pvt Ltd, Vivek has established himself as a trusted leader in guiding businesses through the complex landscape of medical device regulations and quality standards.Vivek is a Qualified Lead Auditor for ISO 13485 and ISO 9001, demonstrating his deep understanding of quality management systems. He has successfully assisted numerous companies in registering their products in markets worldwide, including India, the USA, Europe, Gulf-GCC, Russia-CIS, African and Asian, and Latin American countries.With a strong focus on supporting medical device startups, Vivek has provided end-to-end documentation consulting, encompassing design & development, risk management, ISO 13485 implementation, software verification and validation, clinical evaluation, usability, testing strategy, and preparation of Plant Master Files and Device Master Files. His guidance has empowered these companies to navigate audits with confidence, achieve ISO 13485 certification, and obtain manufacturing licenses in India.Vivek's expertise extends to CE marking technical file creation as per EU MDR 2017/745. He possesses a wealth of experience in dealing with the CDSCO (India) office, assisting companies with manufacturing licenses, imports, clinical trial approvals, and more, across all classes of devices.As an active contributor to the industry, Vivek is engaged in training services and delivers sessions on various medical device subjects such as Clinical Evaluation, Clinical Investigation (ISO 14155), Usability (IEC 62366-1), Design Control (21 CFR 820.30), Risk Management (ISO 14971), Electrical Medical Device (IEC 60601-1), ISO 13485, MDR (EU) 2017/745, and SaMD (IEC 62304).Throughout his career, Vivek has successfully handled a wide range of medical devices, including Implantable/ Active/ Software as Medical Device (SaMD) & SiMD. His expertise spans multiple medical specialties, such as Orthopedic, Ophthalmic, Dermatology, Gynecology, Rehabilitation, Cardiovascular, Dental, Hospital Disposables, Radiation Emitting Products, and Emergency situation products.Vivek holds dual master's degrees, a Master of Technology in Quality Management from BITS Pilani, and a Master of Pharmacy in Regulatory Affairs from JNU Jaipur. He has also completed various training programs conducted by industry experts, further enhancing his ability to serve the medical device industry.