Whether you’re a startup building your first Quality Management System or an established firm facing an FDA 483 or Warning Letter, your QMS is your company’s most valuable asset. A broken QMS isn’t just a compliance risk—it’s a manufacturing bottleneck.
We specialize in “Lean Compliance.” We build ISO 13485:2016 and 21 CFR Part 820 systems that don’t just satisfy auditors—they improve your manufacturing throughput.
Regulatory Terms & Expertise
Our QMS Consulting Covers:
FDA & ISO Submission Consulting
- Audits & Gap Assessments, MDSAP (Medical Device Single Audit Program)
- QSR/GMP-21 CFR Part 820, ISO 13485, ISO 9001
- QS Assessment including all subsystems, i.e. Design Control & Risk Management, CAPA, PAPC, Management Responsibilty
- Compliance; Complaint Handling, Medical Device Reporting (MDRs), Recalls, etc.
- In-house Training
Quality System Regulations & Standards:
- ISO 13485:2016 Quality Management Systems
- FDA 21 CFR Part 820 (US Quality System Regulation)
- EU Medical Device Regulation (MDR 2017/745)
- MDSAP (Medical Device Single Audit Program)
- ISO 14971 Risk Management
- ISO 62304 Software Lifecycle Processes
- IEC 62366 Usability Engineering
Design & Development Controls:
- Design History File (DHF) Development
- Design Input & Output Documentation
- Design Verification & Validation (V&V)
- Design Transfer Protocols
- Design Change Control
- Traceability Matrix Development
Document & Records Management:
- Document Control Systems (ISO 4.2.3 / 21 CFR 820.40)
- Standard Operating Procedures (SOPs)
- Work Instructions & Forms
- Electronic Quality Management Systems (eQMS)
- Record Retention Strategies
- Master Device Record (MDR) & Device Master Record (DMR)
Production & Process Controls:
- Process Validation (IQ/OQ/PQ Protocols)
- Installation Qualification (IQ)
- Operational Qualification (OQ)
- Performance Qualification (PQ)
- Manufacturing Process Controls
- Production Part Approval Process (PPAP)
Supplier & Material Controls:
- Supplier Qualification & Auditing
- Incoming Inspection Procedures
- Approved Vendor Lists (AVL)
- Supplier Corrective Action Requests (SCAR)
Corrective & Preventive Actions (CAPA):
- CAPA System Implementation
- Root Cause Analysis (RCA)
- Complaint Handling & MDR Reporting
- Medical Device Reporting (MDR) to FDA
- Post-Market Surveillance (PMS)
Internal Audits & Risk Management Reviews
- Internal Audit Program Development
- Audit Checklists & Procedures
- Management Review Meeting Facilitation
- Mock FDA Inspections & Notified Body Audits
- ISO 14971 Risk Management File Development
- Failure Mode Effects Analysis (FMEA)
- Hazard Analysis
- Risk Assessment & Risk Control Documentation
