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CDSCO INDIA CONSULTING
Medical Devices
Manufacture
ISO 13485 Implementation
Manufacturing License (MD-5): Class A & B (MD-9): Class C & D
Test Licence to Manufacture (MD 13)
Loan License (MD-6): Class A & B (MD-10): Class C & D
Permission to Conduct Clinical Investigation of Medical Devices (Form MD 23)
Permission to Manufacture Investigational Medical Devices (MD 27)
Importer
Import Licence (MD 15): Class A & B, Class C & D
Test Licence to Import Medical Devices for Testing Purpose MD 17
Permission to Import Investigational Medical Devices MD 27
Authorized Agent Services
In Vitro Diagnostics (IVDs)
Manufacture
ISO 13485 Implementation
Test License to Manufacture (MD 13)
Manufacturing License (MD 5): Class A & B
Manufacturing License (MD-9): Class C & D
Loan License (MD-6): Class A & B
Loan License (MD-10): Class C & D
Permission to Conduct Clinical Performance Evaluation of New IVDs (MD 25)
Permission to Manufacture of New IVDs (MD 29)
Importer
Permission to Import (MD 15): Class A, B, C & D
Test license to Import IVDs for Testing Purpose (MD 17)
Permission to Conduct Clinical Performance Evaluation of IVDs (MD 25)
Permission to Import of New IVDs (MD 29)
Authorized Agent Services
Sale and Purchase License (MD- 42)
Market standing Certificate
Non-conviction Certificate
Free sale Certificate
USFDA CONSULTING
510(k) Submission Support
FDA Establishment Registration and Device Listing
US Agent Support
FDA Pre-Submission (Q-Sub) Support
Software & SaMD Regulatory Consulting
FDA QMSR Compliance Support
CE MARKING CONSULTING
CE Marking for Medical Device
CE Marking for In Vitro Diagnostic Device
European Authorized Representative (EAR)
Clinical Evaluation for Medical Device
Performance Evaluation Services for IVDs
Post-Market Surveillance & Vigilance Support
Technical Dossier Preparation for International Markets
ISO CERTIFICATION
ISO 13485
ISO 9001
ISO 27001
ISO 27701
ISO 42001
ISO 22301
MDSAP
AI-SaMD / Digital Health Services
ISO 42001 certification
SaMD Registration with CDSCO (India)
SaMD Registration in the US
SaMD Registration in the EU
ISO 13485
Cyber Security
NIST Framework Documentation
VAPT (Vulnerability Assessment & Penetration Testing)
SPDF (Secure Product Development Framework)
FDA Cybersecurity Documentation
Risk Management & Threat Modelling
Cybersecurity Testing & Validation
Information Security & Privacy
ISO 27001 (For Information Security Management)
ISO 27701 (Privacy information management systems)
EU AI Act (European Union Artificial Intelligence Act)
Digital Personal Data Protection Act
General Data Protection Regulation
Health Insurance Portability & Accountability Act
SOC 2 Compliance (System & Organization Controls)
Pharmaceuticals Services
Regulatory Affairs & Product Registration
Quality, GMP Compliance & Auditing
Regulatory Writing & Submission Support
Pharmacovigilance Services
Biologicals Services
R&D of Biopharmaceuticals
Clinical development and MA of Biopharmaceuticals
State FDA submission
Emerging market submissions
Cosmetic Services
INDIAN MANUFACTURER
Manufacturing License
Loan License
Registration Renewal
Post Approval Change
Labelling Assistance
Legal Metrology (LMPC)
FOREIGN MANUFACTURER
Import License
CDSCO Authorizing Agent Support
Registration Renewal
Post Approval Change
Labelling Assistance
Legal Metrology (LMPC)
NUTRACEUTICAL SERVICES
FSSAI Registration
Annual Return Filling
Modification of Application
Renewal Filling
Gap Assessment for Labels
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