Technology Engineer Working in Factory. Holding check-list and supervising


Just before your certification audit by a third-party organization you may benefit from our pre-audit services to have a final review of your technical files or quality management system. A detailed audit report will show you pros and cons of your system and our experts would be happy to discuss possible corrective actions in order to fulfil the requirements

MEDLOFT experts can support you in;

  • Mock up Audits
  • Critical supplier/subcontractor audits
  • GAP Analysis for revised standards and regulations
  • Internal Audits

Our specialized team will help you with the GAP analysis for the QMS standards such as ISO 13485:2016 or new revised regulations such as EU MDR / IVDR. The GAP analysis will be performed by a team of expert auditors, depending on the size of your organization.

With the new regulations and revised requirements of ISO 13485:2016 the importance of subcontractor/supplier management has become a core issue for each medical device manufacturer. MEDLOFT can support you in implementing effective control methods on your outsourced processes. Our auditors with notified body experience can be part of your supplier audit team and provide you cost effective solutions on time.

To maintain the effectiveness of its quality management system a company shall have a solid internal audit process. Our auditors with notified body experience can be part of your internal audit team and provide you clear audit reports identifying the corrective action needs of your system.

To have more detailed information about our consultancy services please contact us. We charge you for the work performed there will be no hidden costs.