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About Tacit MedTek
We Helps Various Manufacturers In The Healthcare Industry
Tacit MedTek is a consulting company that provides regulatory guidance and quality compliance services to various manufacturers in the healthcare industry.We serve our clients by providing turnkey services, system implementation, training, licensing, regulatory approvals, and certifications.Tacit MedTek is a vibrant and customer-focused company that provides healthcare product manufacturers across the globe with US, EU & Indian medical device regulatory consultants services.
Tacitmedtek Founder
Vivek Singh
Vivek Singh is founder and director of Tacit Medtek Pvt Ltd. He is an expert for Medical Device Regulatory Affairs and Quality Management and a Qualified Lead Auditor for ISO 13485 and ISO 9001 with 16+ years’ experience in medical device industry. He is helping businesses to register the medical devices worldwide market including India, USA, Europe, Gulf Countries-GCC, Russia- CIS countries, African and Asian counties, Latin America countries.
Vivek has worked extensively with medical device startup companies and have consulted them on end-to-end documentation ranging from design & development, risk management, ISO 13485 implementation, software verification and validation, clinical evaluation, usability, testing strategy, Plant Master File & Device Master File preparation etc. He has helped these companies to face the audits with confidence and achieve the ISO 13485 certification and manufacturing license.
Vivek has rich expertise in CE marking technical file creation as per EU MDR 2017/745 and performs gap analysis in the current documentation. He has good experience in dealing with the CDSCO (India) office for issues related to Manufacturing licenses, Imports, New Registrations, Clinical Trials Approvals, Test Licenses, etc. for all classes of devices.
He is also engaged in training services and provides training on various medical device subject areas like Clinical Evaluation Report preparation (Meddev 2.71), Clinical Investigation (ISO 14155) documentation, Usability Engineering (IEC 62366-1), Design Control (21 CFR 820.30), Risk Management (ISO 14971), Electrical Medical Device Safety Testing (IEC 60601-1), Medical Device QMS (ISO 13485), MDR (EU) 2017/745, Software for Medical Devices (IEC 62304).
He has handled a wide range of medical devices including High-Risk Implantable Medical Devices, Active Medical Devices, Software as Medical Device (SaMD), and Software in Medical Device (SiMD). These products cover medical specialties like Orthopedic, Ophthalmic, Dermatology, Gynecology, Rehabilitation, Cardiovascular, Dental, Hospital Disposables, Radiation Emitting Products, Emergency situation products etc.
Vivek holds dual master’s degree, a Master of Technology (Quality Management) from BITS Pilani and a Master of Pharmacy (Regulatory Affairs) from JNU Jaipur. Also, he is has received various training program from the Industry expert to serve the medical device industry.
