Medical device – Audit

AL Engineering offers value adding mock audits & pre-audit assessments, where the focus is to secure that your business and suppliers are in compliance with current regulations e.g. ISO13485:2016 or MDR2017 or internal requirements.

These audit experiences are based on best practices and the latest trends within the Medical Device industry.

In addition to this AL Engineering offer assistance in relation to upcoming audits or inspections as well as assistance during and after audits and inspections.

  • Mock Audits
  • Pre-Audit assessments
  • GAP analysis
  • Preparation of audits/ inspections
  • Support during audits/ inspections
  • Assistance on answering eventual CAPA’s, warning letters etc.


Please contact Tina Linders for a non-committal talk about how we can make a difference for your company.

+45 2913 2445