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Ensuring Compliance, Consistency, and Confidence in Your QMS
A strong quality management system is the foundation of safe, effective medical devices.
Whether your organization is transitioning to the FDA’s new Quality Management System Regulation (QMSR) or maintaining certification under ISO 13485:2016, an independent internal audit is one of the most powerful tools for identifying risks, strengthening processes, and demonstrating regulatory readiness.
At Medical Devices and Pharma (MDP), we provide objective, process-driven internal audits designed to help you uncover gaps early, correct issues efficiently, and build a quality system that can withstand FDA inspections, auditor scrutiny, and global market expectations.
What Our Internal Audit Covers
Quality System Structure & Documentation
- Quality manual and policy alignment
- Document control and record management
- Change control effectiveness
Design & Development Processes
- Design and development planning
- Risk management integration
- Design transfer and DDF (formerly DHF) compliance
Production & Process Controls
- Process validation
- Device batch records (formerly DHRs)
- Manufacturing controls and traceability
Purchasing & Supplier Quality
- Supplier evaluations and re-evaluations
- Supplier controls under QMSR 7.4 / ISO 13485
- Purchasing data, agreements, and incoming inspections
Corrective and Preventive Actions (CAPA)
- Issue detection and investigation
- Root cause methodologies
- Verification of effectiveness
Complaint Handling & Feedback
- Complaint evaluation and MDR considerations
- Postmarket surveillance alignment
- Trending and feedback integration
Management Responsibility
- Quality planning and management review
- Resource adequacy
- Internal communication pathways
Risk Management
- ISO 14971 integration throughout the lifecycle
- Production/post-production risk evaluation
- Linkage between risk controls and quality system processes
What You Receive
Every engagement includes:
A detailed audit plan. Scope, schedule, and criteria tailored to your organization.
Objective evidence-based findings. Clear identification of conformities, minor nonconformities, major nonconformities, and opportunities for improvement.
A prioritized remediation roadmap. Actionable recommendations mapped to QMSR and ISO 13485 clauses.
A closing meeting and leadership briefing. We make sure management fully understands findings and next steps.
Optional: Follow-up audit / remediation support. We can help implement corrective actions or verify effectiveness.
Why Choose MDP as Your Audit Partner?
We offer a collaborative, non-adversarial audit approach with clear, practical recommendations – not generic checklists.
We have deep experience in FDA-regulated device manufacturing with a network of quality managers and regulatory professionals, and strong expertise in FDA’s QSR-to-QMSR transition and global quality management system alignment. In fact, we wrote the book.
And we offer flexible onsite and remote audit model options. We will meet you where you are – whether you need a full system audit or focused reviews of design control, supplier quality, or production processes.
Are You Ready to Strengthen Your Quality System?
Contact us today to schedule your internal audit or request a customized quote.
