Services By TypeRegulatory Certification
Regulatory certification is the process of confirming manufacturers’ compliance with regulatory requirements utilizing an audit and certification model, e.g. ISO/IEC 17021, to provide an inspectorate function on behalf of participating regulators. This function is differentiated from commercial certification which indicates conformance and registration for trade purposes by elevating it to regulatory compliance to meet legal obligations. Entities providing this function, the Auditing Organizations such as NSF Health Sciences Certification, LLC, have been assessed and formally recognized by participating regulators to perform this function on their behalf.
Latest News
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NSF Health Sciences Certification, LLC Applies to Become MDSAP Auditing Organization
- 2 months ago
ANN ARBOR, Mich. — An application submitted by NSF Health Sciences Certification, LLC, a wholly-owned subsidiary of global public health...
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New CQI/IRCA-Certified Lead Auditor Training is First Based on ISO 13485 and International MDSAP
- 6 months ago
ANN ARBOR, Mich., USA and YORK, UK — NSF International, a global public health and safety organization, is now offering...
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Recognized by regulatory agencies at the local, state, federal and international level, the NSF certification mark means that the product complies with all standard requirements.
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Info Paper: Benefits and Purpose of MDSAP
This paper provides an explanation on MDSAP and the benefits it offers to device manufacturers. Learn more
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Video: MDSAP Overview
Learn more about the MDSAP in this video featuring Kim Trautman, Executive VP, Medical Device International Services. Learn more
