Let's ...
\n\n
\n\ntalk about the problem openly
\n\tmake a sketch to develop a common view
\n\tidentify and involve the key players
\n\t\n\n
... do it!
\n","stylesMapId":"CK_EDITOR_PARAGRAPH_STYLES","linkList":[]},"1nva":{"type":"StyledText","id":"1nva","metaData":{"isPreset":false,"schemaVersion":"1.0","isHidden":false},"text":"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.
\n","stylesMapId":"CK_EDITOR_PARAGRAPH_STYLES","linkList":[]},"k74":{"type":"StyledText","id":"k74","metaData":{"isPreset":false,"schemaVersion":"1.0","isHidden":false},"text":"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!
\n\n
\n\nTechnical file / device master record
\n\tPost market surveillance
\n\tTechnological section of clinical evaluations
\n\tInvestigator's brochure for clinical trials
\n\tDesign risk management
\n\tRemediation projects
\n\tAudit preparation and assistance
\n\tComplaint management
\n\tCAPA / recall
\n\tRegulatory affairs management
\n\tQuality management system documents
\n\t
\n\nWorking languages: EN / DE
\n\nConversation: EN / DE / FR / IT / PT
\n","stylesMapId":"CK_EDITOR_PARAGRAPH_STYLES","linkList":[]},"qq6":{"type":"StyledText","id":"qq6","metaData":{"isPreset":false,"schemaVersion":"1.0","isHidden":false},"text":"\n\n
Are you acting in regulated markets?
\n\n
\n\nDo you maintain technical files to claim and evidence compliance with CE or other national or regional requirements?
\n\n
\n\nAre you inspected by authorities or audited by certifying bodies?
\n\n
\n\nDo you need solutions for compliance?
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