Extensive Documentation Requirements

• Medical Device Regulation (MDR)
• Data protection regulations (GDPR)
• IT security standards
• Hospital-specific accreditation standards

Process Challenges

• Teams perceive compliance work as impediment to flow
• Documentation can lag behind development
• Regulators may be unfamiliar with agile approaches
• Validation needs may conflict with iterative delivery

Integration Solutions

• Embed regulatory work packages into agile process
• Assign additional quality assurance roles per team
• Collaborate closely with compliance experts in LACE
• Automate compliance evidence where possible

Compliance by Design

• Integrate compliance into Definition of Done
• Generate documentation from working patterns
• Use Enabler Stories to address compliance needs
• Develop templates and patterns for consistent documentation

Regulator Engagement

• Involve auditors and authorities early
• Demonstrate how agile process delivers controlled results
• Provide clear traceability from requirements to implementation
• Educate regulators on agile delivery methods

"With careful planning and integration, regulatory compliance can become part of the agile workflow rather than a separate, competing process."