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Accredited Inspection Services for Medical Devices offered by DNV

DNV is ISO/ IEC 17020: 2012 accredited by NABCB as Type A Inspection Body. NABCB is unit of Quality Council of India. NABCB is a full member of ILAC and APLAC as well as signatory to their MRAs for Inspection globally.

Accredited Inspection Services for Medical Devices offered by DNV:

The production of medical devices is a strictly regulated business. In almost all countries, and for most medical and diagnostic products, there are standards to which manufacturers need to demonstrate compliance.

Inspection of medical devices involves the examination of a product design, product, process, or installation and determination of its conformity with specific requirements or, based on professional judgment, with general requirements

Regulators and government bodies inspect compliance as per applicable standards for products/services which they approve. Accreditation assures technical competence. Regulators can rely on accreditation and prescribe Third-Party NABCB Accredited Conformity Assessments.

DNV Business Assurance India Pvt. Ltd. is ISO/ IEC 17020: 2012 accredited by NABCB as Type A Inspection Body for Medical Devices under IAF 19c.

NABCB is a unit of the Quality Council of India. NABCB is a member of ILAC and APLAC as well as a signatory to their MRAs for Inspection globally. NABCB accreditation is recognized worldwide and inspection reports with NABCB accreditation symbol are acceptable internationally.

Government and Regulators at the global level also rely on the IAF and ILAC Arrangements (MLA/MRA) to further develop or enhance trade agreements.

Inspection by DNV will support the manufacturer with freedom of world trade by eliminating technical barriers, realizing the free-trade goal of ‘Tested, Inspected or Certified Once and Accepted Everywhere'.

Benefits of Inspection by DNV:

  • Assurance of Technical Competence, Reliability, and Integrity
  • Effective Risk-based Inspection
  • Well-versed knowledge on Standards / Regulations / Requirements
  • Customer Satisfaction minimizes complaints
  • Facilitates Selection of Suppliers
  • Promotes Confidence in Imports/Exports activities.
  • Avoids re-testing/inspection due to local requirements.
  • Enhances competitiveness, marketing advantage.
  • Increased business acceptance of reports

Frequently Asked Questions

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ISO/IEC 17020:2012 specifies requirements for the competence of bodies performing inspection and for the impartiality and consistency of their inspection activities. It applies to inspection bodies of type A, B or C, as defined in ISO/IEC 17020:2012, and it applies to any stage of inspection, We, DNV has been accredited as Type A inspection body by NABCB under Quality council of India.

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The delivery of services will be at par with the international standard having recognition and acceptance throughout. It will add value to your product as it has been inspected by an accredited Inspection body.

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As inspection will be performed under accreditation ensured along with ILAC and APLAC requirements and guidance documents fulfilment which mutually help us to deliver, enhance and add value to your product giving international acceptance.

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The deliverables will represent and facilitate harmonization of inspection services and to bring our services at par with internationally accredited bodies. Will also provide Mutual Recognition / Multilateral Arrangements/acceptance with regional and international forums/bodies.

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Systematic approach towards inspection of various sectors like IAF 17, 18 , 19a, 19c , 21 & 22

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DNV has been accredited for an International standard having acceptance worldwide, the deliverables will reflect the compliance with the requirement of ISO/IEC 17020:2012 and association of ILAC and Mutual Recognition / Multilateral Arrangements