Documentation

My understanding of documentation goes far beyond mere paper:

  • GDocP (Good Documentation Practice) – More Than a Buzzword, a Philosophy: Sure, GDocP might sound like dry stuff at first. But to me, it’s the recipe for documents that don’t just exist, they live: understandable, readable, punctual, authentic, clearly attributable, precise to the detail, complete (no Swiss cheese documentation!), consistent, resilient, and always readily available. I help you embed these gold standards into your technical documentation and QM system so that information isn’t just present, but also rock-solid and bulletproof in an emergency. Documentation following GDocP minimizes risks and misunderstandings, and it’s the shining hallmark of your professionalism – so that when push comes to shove, the big question mark dance doesn’t begin.

  • The V-Model – Structure with Foresight, Documentation Without Loopholes: Methods like the V-Model aren’t just development guidelines; they’re also excellent tools for documentation that thinks ahead. Imagine the V as a well-planned hiking route: every step on the left side (definition, design) leaves a clear “path description” (documented specifications). On the right side, documented evidence (in the logbook – uh – in the report, of course) confirms that we’ve indeed reached the planned viewpoint. I’ll help you choreograph your projects so that documentation organically grows as a loyal companion. The result: seamless traceability from the initial idea to the final applause (or test report) – an invaluable advantage, not just when the auditor knocks, but also for the collective project memory.

What Does This Mean for Our Collaboration?

Your Documentation Will Be Excellent! My expertise in medical device development is like a Swiss Army knife – versatile and always equipped with the right tool. And one of those tools is always excellent documentation, whether we’re talking about development processes, requirement management, risk management, project management, product development, data science, test and process validation, or automation.

Documents That Fit Together!

For me, documentation isn’t a tedious add-on; it’s the common thread that runs through all activities. Risk management files (per ISO 14971) become active sparring partners in the design process. Requirement documents? They’re the living script for design, verification, and validation. Specifications mark the end of the design and design transfer phases. Reports are the proof that everything was done correctly!

Your Benefits – Short & Sweet:

  • Safety & Conformity: Meeting regulatory requirements and minimizing liability risks.
  • Efficiency: Fewer “Huh?” moments thanks to clear documentation that reduces errors and accelerates development processes.
  • Traceability: Every decision, every change, every test – all neatly logged and easily retrievable.
  • Audit Success: Audits? Bring them on! (Well, almost.) You’ll be perfectly prepared.
  • Knowledge Management: Valuable know-how won’t become secret knowledge held by individuals, but a treasure for your entire company.

Let’s work together to ensure your documentation isn’t just a boring chore, but a true value driver for your company and your innovative medical devices.

Let's work together!