Medical Device Scrum Specialist (m/f/d)

Course overview

The Medical Device Scrum Specialist combines expertise in the regulatory environment of medical devices with agile project management. As a Product Owner, they are responsible for the product vision and prioritize the product backlog while considering the strict requirements of the medical device industry. Their core tasks include ensuring compliance with regulatory requirements during agile development cycles. They facilitate sprint planning, manage stakeholder expectations, and integrate quality management aspects into the Scrum process. The specialist documents decision-making processes, evaluates product risks, and ensures compliant development documentation while maintaining agile principles. Medical Device Audits - Competencies for Process Auditors in the Medical Devices Sector (ISO 13485 - ISO 14971 - MDR - FDA) • Regulatory framework and audit forms for medical devices according to ISO 13485, ISO 14971, MDR, and FDA • Audit methodology and execution according to ISO 19011 with digital technologies • Risk management audits according to ISO 14971 with FMEA and Hazard Analysis • Process audits for Design Control, Production, and Post-Market Surveillance • Supplier audits and supply chain compliance according to MDR and MDSAP • Auditing technical documentation and validation processes • Soft skills & auditor competencies • Quality improvement & root cause analysis of audit findings Project Management - Classical and Agile Methods (Scrum & IPMA) • Project management according to DIN 69901 and IPMA competence model • Strategic project alignment with SWOT analysis and business case • Project initiation and planning with structuring and planning methods • Stakeholder management, risk management, and project communication • Project controlling and success measurement with key figures and variance analyses • Digitalization and sustainability in modern project management • Agile project management and Scrum framework according to the Scrum Guide • Scrum events, product backlog refinement & servant leadership Agile Product Management - The Scrum Product Owner • Agile product management in practice: role, methods, and legal requirements • Product ownership in the Scrum process: backlog management, value maximization & teamwork • Agile tools & frameworks for product design and release planning • Customer-centered product development: methods for discovery & value-driven development • Agile risk management, quality assurance, and compliance in the product development process • AI-based decision support and automation in digital product management • Sustainable product development: ESG, circular economy, and CO₂-optimized design • Exam preparation POI Medical Devices - Regulatory Affairs - Understanding Legal Frameworks (ISO 13485 - ISO 14971 - MDR - FDA) • Medical Device Regulation 2017/745 and In-vitro Diagnostic Regulation 2017/746 • Product classification and conformity assessment procedures according to MDR and IVDR • Technical documentation and qu…

Upcoming dates

• 2026-08-23T22:00:00.000Z · 2026-12-10T23:00:00.000Z · München · Combined Learning
• 2026-08-23T22:00:00.000Z · 2026-12-10T23:00:00.000Z · Bautzen, Sachsen · Combined Learning
• 2026-08-23T22:00:00.000Z · 2026-12-10T23:00:00.000Z · Ludwigsburg, Württemberg · Combined Learning
• 2026-08-23T22:00:00.000Z · 2026-12-10T23:00:00.000Z · Dortmund · Combined Learning
• 2026-08-23T22:00:00.000Z · 2026-12-10T23:00:00.000Z · Heidelberg, Neckar · Combined Learning