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OUR SERVICES

We are offering a wide range of Testing and Certification services for almost any related Industry.

Implant Testing

  • Orthopaedic Bone Plate
  • Orthopaedic Angled Fracture Fixation Devices
  • Metallic Bone Screws
  • Metallic Bone Staples
  • Total Knee Replacement Prosthesis
  • Interamedullary Fixation Devices
  • External Skeletal Fixation Devices
  • Spinal Implants
  • Spinal Implants-Subassemblies for spinal arthrodesis
  • Spinal Screws
  • Spinal Plates
  • Spinal Rods
  • Intervertebral Fusion Device
  • Modular Acetabular Device
  • Modular Prosthesis
  • Intervertebral Fusion Devices
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Medical Device Testing

Materials Characterization

  • Micro structure
  • Hardness measurement
  • Corrosion

 

Testing for Packaging

  • Transport safety Studies
  • Validation of Packaging for medical devices
  • Shelf Life & Ageing Studies
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Medical Electrical Testing

  • IEC 60601-1
  • IEC 60601-1-2
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Certifications

  • Quality Management System (ISO 9001)
  • Quality Management System for Medical Devices (ISO 13485)
  • Environment Management System (ISO 14001)
  • Occupational Health and Safety Management System (OHSAS 18001)
  • Medical Devices (Directive 93/42/EEC)
  • In-vitro Diagnostic Medical Devices (Directive 98/79/EC)
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Auditing

Empanelled Auditing

  • Third Party Auditing for Certification Body and Notified Body for ICMED, Notified Bodies (CE Certification for Medical Devices), Certification Bodies (ISO 9001, ISO 13485), Indian Notified Bodies (MDR 2017 for Manufacturing License)
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Training

  • Regulatory Orientation (Medical Devices)
  • Transition ISO 9001:2015.
  • Transition ISO 13485:2016
  • 21 CFR Part 820
  • MDR 2017 5th Schedule Vth
  • Clinical Evaluation Meddev 2.7.1 Rev. 4
  • Risk Analysis ISO 14971:2012
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