Medical Device Auditing

  • Overview
  • Benefits of Auditing
  • Why Work With NSF?
  • Medical Device Services

Global medical device organizations are seen as one of the most audited industries today, subject to internal audits and multiple external audits from a wide range of regulatory agencies. We understand these challenges and the ever-increasing requirements placed on stakeholders in the global medical device market by regulatory, social and economic changes. We provide a comprehensive range of auditing services to support you, whatever your place in the market.

Benefits of Auditing

Recognizing the varying degrees of support an organization requires during the product lifecycle, we offer a range of services to meet your needs both internally and for external compliance, including quality systems requirements, local and international regulations, market and clinician expectations and ever-increasing patient expectations.

Our auditing services include:

  • Pre-audits and assessments against global regulations, including EU, U.S. FDA, Japan, China, Canada and Australia
  • “Health check” audits, enacting the role of a regulator or notified body to provide a gap analysis of your organization’s compliance and capability to meet external requirements
  • Auditing of design dossiers and technical files for U.S. FDA 510(k), CE mark and other market submissions
  • “Health check” audits against best practices in design control, validation, risk management, CAPA, process and supplier control
  • Due diligence audits to assist all parties with acquisition decisions
  • Auditing of the capability of your supply chain to meet your specifications and requirements
  • Auditing and benchmarking of your organization against QA/regulatory/market requirements
  • Auditing of manufacturing- and technology-related validations, measurement systems, computer software, cleaning, sterilization and packaging validations
  • Audit of design-related validation projects, pre- and post-implementation, testing, scientific and analytical validations
  • Full audit solution management and preparation of audit strategies
  • Development of your organization’s internal audit capabilities through training and coaching

Why Work With NSF?

Our auditors possess specialist knowledge and expertise in all key areas of medical devices. Product competencies include:

  • Orthopedic and dental implants and materials
  • Microbiology and sterilization
  • IVD reagents and devices
  • Ergonomics and usability
  • Cardiovascular devices, including implants
  • Advanced technology medical products (ATMPs)
  • Electromedical devices
  • Animal tissues
  • Drug/device combinations
  • Human blood derivatives
  • Active implants, including pacemakers
  • Biocompatibility and toxicology

Medical Device Services

Our services for the medical device industry include consulting and training in addition to auditing. Each of these services is integrated with the others.

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