Key Challenges in Implementation

Teams in medical devices live under heavy documentation pressure. Ensuring full traceability between requirements, risk controls, tests, and clinical evidence becomes overwhelming, especially across multiple teams and subcontractors. Many companies still rely on spreadsheets, manual document updates, and disconnected tools, which increases the risk of missing links during audits. Regulatory updates (especially MDR/IVDR) add uncertainty, and proving software safety under IEC 62304 often turns into a costly, multi-month effort. V&V leaders face strong pressure to avoid gaps that could block FDA or Notified Body approvals, while project managers struggle to maintain visibility across cross-functional teams.

Relevant Certifications & Standards

• FDA 21 CFR Part 820 – Quality System Regulation
• ISO 13485 – QMS for medical devices
• ISO 14971 – Risk management
• IEC 62304 – Software lifecycle for medical devices
• IEC 60601 – Electrical safety
• MDR 2017/745 – EU Medical Device Regulation
• IVDR 2017/746 – EU In Vitro Diagnostic Regulation
• IEC 62366 – Usability engineering
• ISO 10993 – Biocompatibility

Solution

Vecify gives medical-device teams a single execution layer where requirements, risks, tests, clinical evidence, and design documentation are always connected. AI automates IEC 62304 traceability, identifies missing risk controls for ISO 14971, and flags inconsistencies that could jeopardize FDA or MDR/IVDR audits. Your engineering, quality, and clinical teams finally work in one place, no more spreadsheets, no more manual document rework. Real-time audit readiness replaces months of preparation, de-risking submissions and accelerating time to market.