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Are you acting in regulated markets?

Do you maintain technical files to claim and evidence compliance with CE or other national or regional requirements?

Are you inspected by authorities or audited by certifying bodies?

Do you need solutions for compliance?


M Sc in mechanical engineering with more than 25 years of experience in medical devices, including sterile and / or implantable devices, pharmaceutical packaging materials, quality management and regulatory affairs. Easily adapting to other GMP-like regulated industries such as automotive, aerospace or food.


Let's ...

  • talk about the problem openly

  • make a sketch to develop a common view

  • identify and involve the key players


                                                                    ... do it!


Do you plan to outsource one of the following tasks, be it for a single project or as an ongoing process  -  I will be happy to help!

  • ​Technical file / device master record

  • Post market surveillance

  • ​​Technological section of clinical evaluations

  • ​Investigator's brochure for clinical trials

  • Design risk management

  • Remediation projects

  • Audit preparation and assistance

  • Complaint management

  • ​CAPA / recall

  • Regulatory affairs management

  • Quality management system documents

Working languages: EN / DE

Conversation: EN / DE / FR / IT / PT

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