From Documents to Digital Knowledge – How MedTech Can Future-Proof Compliance | In-Focus Replay скачать в хорошем качестве

From Documents to Digital Knowledge – How MedTech Can Future-Proof Compliance | In-Focus Replay

This Friday In-Focus replay from the MedTech Leading Voice Exchange (MLVx) features Regina Preysing, an experienced engineer and IT consultant turned MedTech documentation strategist, in a thought-provoking session on transforming traditional document-based systems into structured, digital knowledge management. Drawing on decades of cross-industry experience, Regina explains why static SOPs and siloed file repositories can slow compliance, introduce errors, and block innovation. She outlines how modular, reusable, and traceable information structures—rooted in regulatory frameworks—can speed change control, improve audit readiness, and prepare companies for new regulations like environmental compliance and cybersecurity. From analogies that make the concept tangible (think recipe books and ingredient lists) to examples of tool capabilities and real-world implementation challenges, this discussion reframes “documentation” as a living, dynamic asset that fuels faster, smarter regulatory response. Chapters: (00:00) – Welcome & Introduction to Digital Knowledge Management (01:56) – From Engineering to Documentation Strategy (04:33) – Why Regulators Require Detailed Documentation (06:37) – Patient Safety, Traceability & Audit Evidence (08:57) – Small Change, Big Impact: The Ventilator Screw Example (12:34) – Avoiding Over-Specificity in Processes (15:09) – Digital vs. Electronic: Key Differences (17:19) – The Recipe Book Analogy: Static vs. Dynamic Knowledge (22:41) – How Structured Knowledge Enables Faster Change (27:46) – Lessons from Content Management Systems (31:57) – Document-Based vs. Knowledge-Based: A Side-by-Side Comparison (35:33) – First Steps to Transition & Starter Processes (CAPAs, Change Requests) (38:27) – Example Tools & Cost Considerations (46:52) – Regulatory Frameworks as Built-In Architecture (50:31) – Adapting for New Standards & Cybersecurity (52:10) – Germany’s MDKU Community Data Model Project (56:16) – Affordable Access Models & Closing Remarks About Friday In-Focus: Friday In-Focus is MLVx’s weekly webinar series—always free, always interactive—spotlighting MedTech’s most experienced thinkers and doers Join the MLVx community: https://members.mlvexchange.com Use code SEAN20 to save 20% on membership.