Medical Devices Quality & Regulatory Auditing Services

With former Notified Body staff on board, Medaptivo offers extensive experience and quality assurance expertise across all areas of medical device compliance audits. 

Whether it’s for new certification or renewal, we help manufacturers prepare for QMS and regulatory inspection by conducting remote audits in accordance with MDD 93/42/EEC, EU 2017/745 MDR, EN ISO 13485:2016 and the Medical Device Single Audit Program (MDSAP).

We offer the following key on-site or desktop auditing services:

  • Gap/Preliminary Assessment Audits to MDD, MDR, ISO 13485:2016 and Medical Device Single Program (MDSAP) to determine level of compliance, gaps, and potential areas for improvement
  • Pre-Inspection Audits (Initial Certification, Renewal or Scheduled Surveillance) to MDD, MDR, ISO 13485:2016 and MDSAP to prepare for regulatory inspections and address outstanding deviations
  • Internal Audits - complete quality management system audits to MDD, MDR, ISO 13485:2016 or internal standard operating procedures
  • Mock Unannounced Audits in line with MDD/MDR to determine an organisation’s level of preparedness for inspections by notified bodies and competent authorities
  • Subcontractor/Supplier Audits to establish vendor compliance to the applicable QMS and/or regulatory requirements, as well as compliance of subcontracted components, sub-assemblies or finished products in accordance with agreed manufacturer specifications

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