Our Services
QUALITY MANAGEMENT SYSTEM DEVELOPMENT
- ISO 13485 Medical Devices QMS
- ISO 14971 Medical Devices Risk Management
- ISO 9001 QMS Requirements
- 21 CFR Part 820 Quality System Regulation
- EU Medical Device Regulation (MDR)
- EU In Vitro Diagnostic Regulation (IVDR)
- Standard Operating Procedure (SOP) Development
.jpg/:/cr=t:0%25,l:0%25,w:100%25,h:100%25/rs=w:1209,cg:true)
QUALITY MANAGEMENT SYSTEM SUPPORT
- QMS System Improvements
- QMS Assessment, & Remediation
- CAPA and Nonconformance Management
- Root Cause Analysis
- Complaints Management
- Process validation (IQ/OQ/PQ)
- Document & Change Control
- Standard Operating Procedure (SOP) Optimization
eQMS Development and Management
Experienced in the implementation and management of eQMS, including:
- Greenlight Guru
- Excellence Through Quality (ETQ)
- Qualio
- QT9
PROJECT MANAGEMENT
- Quality Systems Implementation
- Medical Device Design Controls
- Implementation of Quality Assurance Manuals, Standard Operating Procedures, Work Instructions
- Risk management program development and analysis
- Technical File Development
FDA ENFORCEMENT SUPPORT
- 483 Warning Letter Response
- FDA Inspection Preparation
- FDA Inspection Readiness Training
AUDITING
- MDSAP Auditing
- Internal Auditing
- Supplier Audits
- Technical File Audits
- Due Diligence Audits
- On-site or Remote Auditing
- Audit Management
TRAINING
- Medical Device Quality System Regulations (QSR)
- Good Manufacturing Practices (cGMP)
- Good Documentation Practices (GDP)
- Corrective and Preventive Actions
- Failure Investigation & Root Cause Analysis
- Auditing Practices (MDSAP, Internal, Supplier)
- Audit & Inspection Readiness Training