Medical Devices Quality Management Systems
QM 069
ACM EMB Pvt. Ltd.
Address 29 B/48, Vrindavan Complex, New Mandi, Muzaffarnagar-251001, U. P, India
Contact Person Mr. Puneet Gupta
Designation Director
Tel +91 9029527001
Email ID
Valid From April 08, 2021
Valid Upto Jul 07, 2024
Accreditation Standard ISO/IEC 17021-1:2015 and IAF MD 9
Scopes of accreditation
ISO 13485 - Medical Devices Quality Management Systems
Main Technical Areas
(as per IAF MD 8)
Description (Main Technical Areas) Technical Areas
A1.1 Non-Active Medical Devices General non-active, non-implantable medical devices
Non-active implants
Devices for wound care
Non-active dental devices and accessories
Non-active medical devices other than specified above
A1.2 Active Medical Devices (Non-Implantable) General active medical devices
Devices for imaging
Monitoring devices
Devices for radiation therapy and thermo therapy
Active (non-implantable) medical devices other than specified above
A1.4 In Vitro Diagnostic Medical Devices (IVD) Reagents and reagent products, calibrators and control materials for:
  • Clinical Chemistry
  • Immunochemistry (Immunology)
  • Haematology / Haemostasis / Immunohematology
  • Microbiology
  • Infectious Immunology
  • Histology/Cytology
  • Genetic Testing

In Vitro Diagnostic Instruments and software
IVD medical devices other than specified above
A1.5 Sterilization Method for Medical Devices Ethylene oxide gas sterilization (EOG)
Moist heat
Radiation sterilization (e.g. gamma, x-ray, electron beam)
Sterilization method other than specified above
A1.7 Parts or Services Raw materials
Calibration services*
Distribution services
Maintenance services
Transportation services
Other services
* Organizations providing calibration services should be accredited to ISO/IEC 17025
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