Prowa Medical Instruments | Certifications

Accrediations & Certifications

The QA team of Prowa Medical Instruments regularly updates the documentation & policies to make sure that the company comply with the latest international regulations.

ISO 9001 - Quality Management

ISO 9001 Certificate

ISO 9001

ISO Certificate Confirmation

ISO 13485 - QMS for Medical Devices

ISO 13485

ISO Certificate Confirmation

U.S. Food and Drug Administration (FDA)

GMP, US FDA

GMP, US FDA

GMP, US FDA

GMP, US FDA

European Authorized Representative (EC REP)

EUAR Certificate

CMC Medical Devices & Drugs S.L., Spain

Page 01

EUAR Certificate

CMC Medical Devices & Drugs S.L., Spain

Page 02

EUAR Certificate

CMC Medical Devices & Drugs S.L., Spain

Page 03

EUAR Certificate

CMC Medical Devices & Drugs S.L., Spain

Page 04

EUAR Certificate

CMC Medical Devices & Drugs S.L., Spain

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European Database on Medical Devices (EUDAMED)

EUDAMED Actor Information

Single Registration Number (SRN)

Economic Operators

EUDAMED Actor Information

Single Registration Number (SRN)

Economic Operators

EUDAMED Actor Information

Single Registration Number (SRN)

Economic Operators

EUDAMED SRN

CE Marking

CE Marking Certificate

EC Declaration of Conformity

EC Declaration of Conformity

Page 01

EC Declaration of Conformity

Page 02

Quality Management Certifications

ISO 7151

ISO 7153-1

ISO 11135

ISO 13402

ISO 17664

ISO 17664-1

ISO 21850-1

ASTM A380-06

ASTM F899-20

Registration, Evaluation, Authorisation and Restriction of Chemicals

REACH (EC)

Medical Device Risk Management

ISO 14971

Technically Competent Testing Laboratory

ISO/IEC 17025

Identification and Labels on Medical Devices

ISO 15223-1

ISO 20417

Sterilized Packaging for Medical Devices

ISO 11607-1

Occupational Health and Safety (OH&S) Management System

ISO 45001

Environmental Management System

ISO 14001

No Child Labour

No Child Labour

Global Medical Device Nomenclature

GMDN Certificate

Sialkot Chamber of Commerce & Industry

SCCI Membership Certificate

SCCI Profile Certificate

SCCI Free Sale Certificate

Surgical Instruments Manufacturers Association of Pakistan

SIMAP Membership Certificate

SIMAP Free Sale Certificate

Sialkot Material Testing Laboratory

Analytical Test Report

AISI 420 Grade

Analytical Test Report

AISI 420 Grade

Analytical Test Report

AISI 420 Grade

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