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YOUR CHALLENGE ... IS MINE

 

Are you acting in regulated markets?

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

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Are you inspected by authorities or audited by certifying bodies?

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Do you need solutions for compliance?

ABOUT ME

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.

STYLE

Let's ...

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  • talk about the problem openly

  • make a sketch to develop a common view

  • identify and involve the key players

 

                                                                    ... do it!

​SERVICES

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!

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  • ​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

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Working languages: EN / DE

Conversation: EN / DE / FR / IT / PT

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