Welcome Our DI Quality Certification Company
Mob: +91 814 866 6078
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Effective Training Programs
Global Medical Device
QMS Certification
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Effective Training Programs
Global Medical Device
QMS Certification
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Effective Training Programs
Global Medical Device
QMS Certification
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Service 2.1

Third Party Audit and Certification Services

Improving quality and maintaining safety, is the best way for a medical device manufacturing company to achieve the required results, thus enabling them to raise their profile and grab new opportunities.Certification of a management system helps to achieve this and provides evidence to the customers and the market, about the client's compliance towardsthe international standards. Hence, a successful audit and certification process, is the outcome of a prompt third-party certification body such as DI QUALITY CERTIFICATIONS SERVICES PVT. LTD.

We at DI QUALITY CERTIFICATION SERVICES PVT. LTD. provideAudit and Certification services of ISO 13485 (Medical Devices QMS)-Third party Audit, Certification, Surveillance and Recertification services for ISO 13485 standard.

Service 2.2

Life science Division

Chemical Analysis Testing:

Chemical testing and analysis is undertaken for identifying, characterizingand verifying the quality of materials used in the medical devices.

Electrical Safety Requirements:

Electrical safety testing is carried out to evaluate the potential risk of electrical shocks to user while using a medical device.

Electromagentic Compatibility (EMC) Testing:

Electromagnetic compatibility (EMC) testingmeasures the ability of active medical devices to function satisfactorily in electromagnetic environment without electromagnetic disturbance.

Packaging Testing:

The Packaging of medical devices shall be tested to verify if it can withstand the transportation and environmental conditions so that the integrity of packaged medical device is maintained.

Service 2.3

Training

List of Trainings provided by us:

  • ISO 9001 Quality management systems - Requirementsawareness training
  • ISO 9001 Quality management systems - Requirements Internal auditor training
  • ISO 9001 Quality management systems - Requirements Lead auditor training
  • ISO 9001 Quality management systems for medical devices - awareness training
  • ISO 13485 - Rquality management systems for medical devices Internal auditor training
  • ISO 13485 Quality management systems for medical devices - Lead auditor training
  • EU Medical Device Regulation - Introduction training course
  • EU Medical Device Regulation implementation training course
  • EU IVD Medical Device Regulation - Introduction training course
  • US FDA 21 CFR requirements - Introduction training course
  • Introduction to Medical devices - Application of risk management to medical devices-ISO 14971
  • Introduction to EN ISO 11135 part 1 and part 2 Sterilization of health care products - Ethylene oxide
  • Introduction to EN ISO 11137 part 1 and part 2 Sterilization of health care products - Radiation
  • Introduction to EN 10993-1 , Biological evaluation of medical devices - Part 1: Evaluation and testing within a riskmanagement process
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Contact

Floor 1, Plot No. A-38, SIPCOT IT Park,

Siruseri, Kanchipuram District,

Tamil Nadu-603103