Offered Services

I can help you with the following

  • As interim people manager in relation to your QA/RA department
  • As project manager for cross functional activities
  • Assist you in setting up the frame for your Quality Management Systems: Document Control, training, Non-Conformities, CAPA’s, Customer Complaints, Change Management, Internal audits, Quality Management Review etc.
  • In relation to Quality measurements, assist you in defining what to measure and how to show associated trending
  • Assist you with development and implementation of specific lean Quality Processes, incl. development of procedures, instructions and templates
  • In relation to your products I can assist you with interpretation of regulations and standards, i.e. EU-MDR, MDD, ISO 13485, 21 CFR part 820 (FDA) related to Quality Management Systems for medical devices
  • I can help you manage preparations for, and hosting of external audits and inspections from authorities and notified bodies incl. management of follow up activities, should you get findings…
  • I can assist you with some Regulatory Affair activities, i.e. including review of risk management files and IFU’s
  • In relation to suppliers, I can assist you with Quality Agreements, setting up supplier audit programs, trending of supplier performance etc.
  • Education and coaching of staff within Quality Assurance and development of courses in line with your specific business needs
  • … any many more activities as per your request….

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European Medico Consult ApS      Weysesgade 44      DK-2100 Copenhagen      Denmark      CVR: 40732241