MEDICAL DEVICE CONSULT SERVICES

Licenses ISO Certifications CE Marking Export Registrations Import Registrations Authorized Representative Services
Document Writing Facility Designing

Manufacturing Licence in Form 28 ISO 9001:2015 CE Medical Device as per Directive 93/42/EEC US FDA Establishment Registration From 41 IAR Agreements QMSP- Quality Management System Procedure (STS, STP, SOP)  
Manufacturing Licence in Form MD-5(Class A & B) MD-7 (Class C & D)  (MDR 2017) ISO 13485:2016 CE IVD as per Directive 98/79/EC US FDA Device Listing For Class-I (510(k) Exempt Devices Form 10 (Drugs & Registered Medical Devices) EAR Agreements QM- Quality Manual  
Loan License on Form MD-4  (Class A & B)  and MD-6 (Class C & D) (MDR 2017) ISO 14001:2015 Transition EU MDR MDR 2017-745. Medical devices IVDR 2017-746 In-vitro Diagnostic Medical Devices US FDA 510(k) for Medical Devices Form 10 for IVD’s   SMF- Site Master File  
Renewal of Manufacturing Licence 28 OHSAS 18001:2007   EU FSC Export Permissions   VMP- Validation Master Plan  
Issue of WHO G.M.P. Certificate. ICMED 9000   CFG USFDA New Product Approval – Rule 122   DMF – Device Master File  
Issue of COPP. ICMED 13485     Cosmetics Import Registration Form 43   DHS- Device History File  
Issue of good Manufacturing Practices (GMP) Certificate 21 CFR Part 820

        TC- Technical Files  
Issue of Non-Conviction Certificate           Risk Analysis  
Issue of Performance Certificate           Clinical Evaluation  
Issue of Validity Certificate              
Issue of GLP Certificate              
Free Sale Certificate              
Issue NOC from CDSCO              
Test License on Form 29