Manufacturing Impact Reports
Real compliance transformations with measurable outcomes. From cardiovascular implants to diagnostic equipment.
Ovation Medical
Class IFDA Class I — Orthopedic Braces & Supports
Challenge
Ovation Medical's QMS was built entirely around EU MDR requirements and contained zero FDA-specific content. The FDA QMSR enforcement date of February 2, 2026, had already passed when they engaged VigilaMed. Their system scored just 31% compliant across 31 applicable requirements, with 16 gaps identified — 10 of which were rated Critical. An FDA inspector would have issued Form 483 observations on day one.
Approach
- Conducted forensic gap analysis across 49 QMSR clauses covering 6 FDA CFR parts
- Mapped all Class I exemptions (18 of 49 requirements exempt) to focus remediation on the 31 that still applied
- Prioritised 9 remediation tasks using regulatory dependency mapping, starting with MDR reporting (21 CFR 803) and corrections and removals (21 CFR 806)
- Rewrote complaint handling to link triage directly to FDA MDR reportability criteria under 820.198
- Corrected record retention to FDA lifetime+2 years and aligned the quality manual, document matrix, and labeling references
- Dual-verified every finding with a second independent VigilaMed assessor
Outcomes
“We evaluated six companies, including two we'd worked with before. By the time VigilaMed came to the first meeting, they already knew what we needed and what we didn't.”
— Kenji Watabe, VP Operations, Ovation Medical
Terumo Aortic
Class IIIClass III Cardiovascular Implants
Challenge
Complex complaints backlog for high-risk devices, extended complaint closure timelines threatening vigilance compliance.
Approach
- Redesigned complaints triage process for risk-based prioritization
- Implemented medical device reporting (MDR) workflow optimization
- Trained complaints team on global regulations and the new process for complaint handling
- Created cross-functional review process (R&D, Manufacturing, RA)
Outcomes
Biosil
Class IIMedical-Grade Silicone Devices
Challenge
Manual vigilance reporting, inconsistent complaints and adverse event reporting documentation
Approach
- Established six sigma methodology to introduce process improvements
- Updated SOP's, WI's and forms to document the process
- Established KPI's for on time reporting and complaint closure
Outcomes
Multi-Site Manufacturer
Class I & IISurgical Instruments & Diagnostic Equipment
Challenge
4 manufacturing sites with inconsistent QMS and a CAPA system not working effectively
Approach
- Standardized SOPs across all manufacturing locations
- Introduced six sigma methodology to CAPA process
- Created CAPA effectiveness verification process and KPI's
- Cross site training provided