Regulatory Intelligence
Manufacturing Impact Reports
Real compliance transformations with measurable outcomes. From cardiovascular implants to diagnostic equipment.
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
20%
Reduction in complaint closure timelines
Zero
Observations in subsequent regulatory audit
100%
On-time adverse event report submissions to MHRA, FDA, PMDA, TFTA, ANVISA and various EU member states
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
Increased
Complaint on time closure rate
100%
On time adverse event reporting to multiple regulatory authorities
Zero
Findings after 3 day vigilence audit by ANSM
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
Outcomes
Unified
CAPA process across all 4 sites
Robust
Root cause analysis using six sigma tools
Decrease
Recurring and unnecessary CAPAS
Communication
Improved across all sites leading to CAPA actions being implemented more efficiently