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
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make a sketch to develop a common view
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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
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Post market surveillance
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​​Technological section of clinical evaluations
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​Investigator's brochure for clinical trials
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Design risk management
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Remediation projects
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Audit preparation and assistance
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Complaint management
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​CAPA / recall
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Regulatory affairs management
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Quality management system documents
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Working languages: EN / DE
Conversation: EN / DE / FR / IT / PT