Building Quality Management for your organisation

Medical Device Consult offers to establish a Quality Management System based on ISO 13485:2016 and/or US 21 CFR part 820 to ensure that the device will be developed, tested, manufactured and documented in accordance with relevant regulatory requirements.

As the industry moves from the Medical Device Directives (AIMD/MDD/IVDD) to the Medical Device Regulation (MDR/IVDR) it is important to understand the implications on the quality management system. Medical Device Consult is available to support you through this transition.

Quality Management Services

Medical Device Consult can assist in:

  • Establishing a Quality Management System according to the regulations for medical devices, containing required quality manual, procedures and forms
  • MDR/IVDR Gap Analysis
  • Risk Management of your company
  • Evaluation and upgrade of your QMS based on a GAP-analysis
  • Conduct of internal or supplier audits
  • Preparing for external audits by Notified Bodies and authorities
  • Training in MDR, IVDR and ISO 13485:2016
  • Act as your QA/RA Manager