Tacit MedTek is a consulting company that provides regulatory guidance and quality compliance services to various manufacturers in the healthcare industry
Healthcare RegulatoryConsulting& Quality Compliance Services
Tacit MedTek is a consulting company that provides regulatory guidance and quality compliance services to 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.
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.
Tacit MedTek
Our Service
Manufacturing License
We help customers to obtain the manufacturing license by preparing the dossier as per CDSCO requirements
Import License
We help customers to search predicate device & compare Indian predicate device with device under registration.
Test License
We help the customer to file the correct application and so deccan easily get the test licence for their business.
India Regulatory Services
We at Tacit MedTek can help you with complete regulatory support for your India operations
ISO 13485 .. Certification
We at Tacit MedTek help customers to get ISO 13485 Certification for their devices.
Compliance with Quality Management System
We assist in ensuring compliance with the Quality Management System for your business
Wholesale Distribution License (Form 20B and 21B)
We help customers to comply with the requirements and obtain the ....... licence.
CE Marking Services as per EU MDR ....2017 / 745
We help customers to get CE Mark Consulting Services as per EU MDR 2017/745
Permission to conduct Clinical Investigation of Medical Devices
We help you to get Permission to conduct Clinical Investigation of Medical Devices
How We Work
Your Medical Device Compliance Partner
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Book an Appointment
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Discuss about your Needs
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Give Best Solution
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Prescribe & Payment
Happy Clients
Years Of Experience
Satisfaction
Testimonials
What Our Clients Say About Us
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.
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