We have over 15 years experience

MEDICAL DEVICES, In-vitro Medical Devices, COSMETICS & PHARMACEUTICALS REGULATORY & CONSULTANCY SERVICES

Medical Devices and In-Vitro Medical Devices manufacturing companies are required to comply with Indian Medical Device Rules 2017, Regulation (Eu) 745/2017, Regulation (Eu) 746/2017, ISO 13485, US FDA 21 CFR 820 Quality System Regulations and Pharmaceuticals & Cosmetics Manufacturing Company required to comply with Drugs and Cosmetics Act 1940 and Rules their under.​

We understand that becoming conversant with CDSCO, European Regulations and US FDA Regulations can be very challenging.

Achievements

Total 24 Clients get Mfg. Lic in Form MD-9 for Class C & D Medical Devices which covers scope of Sterile Suture, Internal prosthetic implants, Bone wax, Orthopaedic Implants, Nebulizer etc.
Total 37 clients get Mfg. Lic in Form MD-5 for Class A and Class B which covers scope of iv Cannula, iv sets, transfusion sets, syringe, catheters, medical equipments, Surgical Dressings etc.
Total 7 Clients get CE Certification
Total 12 USFDA 510k Submission
21 Clients get ISI Mark
18 Clients get Pharmaceuticals Mfg License
Best domain experts

Each wing of our entity is led by the best domain experts that create value in Regulatory Compliance

Regulatory Approvals

We focus on providing services in realistic time frame and cost effectively.

Best Support

Call us at: +91 8307157053
Write to us at: veteran.ecrep@gmail.com

MEDICAL DEVICES, In-vitro Medical Devices, COSMATICS & PHARMACEUTICALS REGULATORY & CONSULTANSY SERVICES

We provide Solution Based Services for:

CE Marking according to Regulation (Eu) 745/2017 & Regulation (Eu) 746/2017
Transition of MDD CE Certificate to MDR (Eu).
Facility Registration, Device listing (Class I), USFDA (510k) & PMS Submission
Medical Devices Manufacturing Licence application on CDSCO portal for Risk Class A, B, C & D
ISI Marking, GeM Registration, NSIC registration
Medical Devices registration with CDSCO
Import Licence for Medical Devices, Pharmaceuticals & Cosmetics
Manufacturing Licences for Pharmaceuticals and Cosmetics in form 25 , 28 & 32
Whole Sale Lic for Drugs
Uploading of Pharmaceuticals Formulation on Sugam Portal
Device Master File preparation, Plant Master File preparation, Technical Construction File & Design Dossier Preparation
Software Validation /ETO Sterilizer Software Validation, ETO Sterilizer Validation as per ISO 11135.
Issuance of Free Sale Certificate, GMP Certificate, QMS Certificate
Training & Visits (Facility Audit)
Indian Authorized Agent / Representative for Foreign Manufacturers
European Authorized Representative (EC REP), People Responsible for Regulatory Compliance (PRRC) Services for Indian Company
Medical Device Single Audit Program (MDSAP)
Brazilian Health Regulatory Agency (Anvisa)
Therapeutic Goods Administration (TGA) | Australia
Medical Devices Regulations Canada
Global Medical Devices Approval and Registration

MEDICAL DEVICES / In-Vitro Medical Devices QUALITY MANAGEMENT SYSTEM IMPLEMENTATION AND CERTIFICATION CONSULTING SERVICES

We provide Solution Based Services for:

Global Quality System Development, Implementation and Certification (ISO 9001 / ISO 13485 / US FDA 21 CFR 820 QSR / CMDR / JPAL / GMP / CFR /MDSAP (Medical Devices Single Audit Program) ANVISA, Health Canada, TGA Australia)
Risk Analysis and Risk Management for all Classes of Medical Devices and IVDs as per ISO 14971 requirements.
Clinical Evaluation as per Meddev and ISO 14155 requirements
Technical Construction File , Design Control Documentation Design History File (DHF)
Sterilization Method Validation and Documentation as per ISO 11135, ISO 11137, ISO 17665 requirements
Clean Room Validation Documentation and Methods as per ISO 14644 series of Standards
Medical Device Packaging Validation Documentation Requirements and Method of Validation as per ISO 11607-1 and ISO 11607-2 requirements
Medical Device Post Market Surveillance and Vigilance Requirements
Cleaning method Validation Document Requirements and Method of Validation
Quality Manual, QMS Procedure