QCentric Certifications Private Limited

Medical Device Testing

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Medical Device Testing Laboratory
Medical Device Testing Laboratory
Medical Device Testing Laboratory

Independent testing solutions to support safe, compliant, and market-ready medical devices.

Medical device testing is essential to demonstrate compliance with regulatory requirements and to ensure that devices perform safely and reliably throughout their intended use. QCentric provides comprehensive medical device testing services covering mechanical, material, packaging, and performance evaluations.

Our testing approach is risk-based, standards-aligned, and designed to generate reliable data for regulatory submissions, certification, and market approval.

Scope of Medical Device Testing

We offer testing services across a wide range of medical devices, including sterile and non-sterile products, implantable and non-implantable devices, and disposable and reusable medical devices.

Testing Capabilities

Our medical device testing services include:

Mechanical & Physical Testing

  • Fatigue and endurance testing

 

Materials Characterization

  • Microstructure analysis
  • Material composition evaluation
  • Corrosion and durability studies
  • Packaging & Transport Studies for sterile medical devices

 

Packaging validation for medical devices

  • Transport simulation and safety studies for sterile medical devices
  • Integrity testing to ensure sterile barrier performance for sterile medical devices

 

Shelf Life & Aging Studies

  • Real-time and accelerated aging studies
  • Shelf-life validation and performance assessment

 

Bio-Mechanical Studies

  • Performance testing for medical devices and implants
  • Functional validation under simulated use conditions

 

Biological Evaluation:

  • Biological Evaluation Plan
  • Biological Evaluation Report

Standard Covered

Sr. No. Standard Number Details
1 ASTM F382-14(2020) Standard Specification and Test Method for Metallic Bone Plates
2 ASTM F384-17(2022) Standard Test Method for Static and Dynamic Testing of Bone Plates
3 ASTM F366-17(2022) Standard Test Method for Evaluation of Structural Properties of Metallic Bone Screws
4 ASTM F543-17(2021) Standard Specification and Test Methods for Metallic Medical Bone Screws
5 ASTM F564-17(2022) Standard Specification for Metallic Bone Staples
6 ASTM F1264-16(2021) Standard Specification and Test Methods for Intramedullary Fixation Devices
7 ASTM F1541-17(2021) Standard Specification and Test Methods for External Skeletal Fixation Devices
8 ASTM F1717-21 Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model
9 ASTM F1798-21 Standard Test Method for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms of Spinal Implant Assemblies
10 ASTM F1820-13(2021) Standard Test Method for Determining the Axial Distraction Force of Spinal Implant Assemblies
11 ASTM F1829-17(2021) Standard Test Method for Evaluating the Static and Fatigue Properties of Spinal Implant Assemblies in Compression
12 ASTM F2009-20 Standard Test Method for Determining the Axial Torsional Properties of Spinal Implant Assemblies
13 ASTM F2068-15(2022) Standard Specification for Wrought Titanium-15 Molybdenum Alloy for Surgical Implant Applications
14 ASTM F2077-18(2021) Standard Test Methods for Intervertebral Body Fusion Devices
15 ASTM F2193-20 Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment
16 ASTM F2267-18(2021) Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment
17 ASTM F2502-17(2021) Standard Practice for Marking Medical Devices for Safety in the Magnetic Resonance Environment
18 ASTM F2706-18(2021) Standard Test Method for Determining the Subsidence Resistance of Intervertebral Body Fusion Devices
19 ASTM F2777-16(2021) Standard Guide for Full-Scale Hydrostatic Testing of Orthopaedic Implants
20 ASTM F3210-22 Standard Test Method for Fatigue Testing of Patient-Specific Spinal Implants
21 ISO 6892-1:2019 Metallic Materials — Tensile Testing — Part 1: Method of Test at Room Temperature
22 ISO 6475:1989 Implants for Surgery — Metal Bone Screws with Asymmetric Thread and Spherical Under-Surface — Dimensions
23 ISO 7206-2:2011 Implants for Surgery — Partial and Total Hip Joint Prostheses — Part 2: Determination of Resistance to Wear
24 ISO 7206-4:2010 Implants for Surgery — Hip Joint Prostheses — Determination of Endurance Properties of Femoral Components
25 ISO 7206-6:2013 Implants for Surgery — Determination of Fatigue Properties of Femoral Stems
26 ISO 7206-10:2018 Implants for Surgery — Determination of Resistance to Static Load of Modular Femoral Necks
27 ISO 7206-12:2016 Implants for Surgery — Determination of Strength of Neck Region of Stemmed Femoral Components
28 ISO 7206-13:2016 Implants for Surgery — Determination of Resistance to Torque of Head Fixation
29 ISO 9585:1990 Implants for Surgery — Determination of Bending Strength and Stiffness of Bone Plates
30 ISO 14242-1:2014 Implants for Surgery — Wear of Total Knee-Joint Prostheses — Part 1
31 ISO 14801:2016 Dentistry — Implants — Dynamic Fatigue Test for Endosseous Dental Implants
32 ISO 14879-1:2020 Implants for Surgery — Total Knee Joint Prostheses — Determination of Endurance Properties
33 ISO 22683:2022 Dentistry — Rotational Adaptability Test for Dental Implant Systems
34 IS 1608:2022 Metallic Materials — Tensile Testing at Ambient Temperature
35 IS 14229:1995 Orthopaedic Implants — Bone Plates — Specification
36 ISO 11607-1:2019 Packaging for Terminally Sterilized Medical Devices — Part 1
37 ISO 11607-2:2019 Packaging for Terminally Sterilized Medical Devices — Part 2

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QCentric Certifications Private Limited

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Q-Centric

QCentric Certifications Private Limited is built on the principle that medical device testing demands diligence, competence, and accountability. We perform independent testing and assessments to support safety, performance, and regulatory compliance across the medical device lifecycle.

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Contact

2nd Floor, SCO 9, DLF Valley Bazaar, Chandi Mandir, Panchkula, Haryana – 134107, India

Call: +91-8076880013
Email: [email protected]

Partner with QCentric for compliant, credible, and competent testing solutions.

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