Quality Assurance

Assuring the right quality in all aspects of your business is vital for your company’s image and success.

We believe that all employees play an important role in securing your quality. We understand your business and are able to help you in developing a Quality strategy and uncover, describe, implement, communicate and follow-up on the processes and guidelines needed to efficiently apply to the specified standards.

Examples of areas in which we can make a difference for you:

  • Development and establishment of QMS according to ISO13485, CMDCAS, QSR 820
  • Planning and execution of internal and supplier audits according to ISO 13485, CMDCAS, QSR 820
  • Preparing for external audits
  • Qualified Person (QP)
  • Interim QA Manager

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  • GAP analysis – monitoring and adjustment of your quality management system
  • Design Controls
  • Risk Management according to ISO 14971 – Development of Risk Plan, Risk Analysis, Risk Management Report
  • CAPAs
  • VV activities (Verification/Validation)
  • FSCA, Customer Complaints
  • Establishment of SOPs

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  • Standard Updates
  • Support prior to, during and after market compliance audits by the competent authorities/Notified Body
  • Establishment of QAP
  • Labeling (Labels, IFU)

Ask Me

Michael Funder Managing Director B.Sc Engineering Direct (+45) 20 64 41 46 mf@medicologic.com

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