Quality System Development
Outsourced QMS Development, Auditing, and Compliance Support
Building and maintaining a compliant quality management system requires specialized expertise that most small to mid-size medical device and IVD companies don’t have in- house.
AJW Technology Consultants provides outsourced quality management services. Our experienced consultants develop, implement, and maintain QMS, conduct internal and supplier audits, and support FDA inspections and certifications, functioning as your quality department without full-time hiring costs
Quality Management System Development
We develop quality management systems specific to your products, operations, and target markets, covering FDA QSR/QMSR, ISO 13485, ISO 9001, EU MDR, EU IVDR, and MDSAP requirements.
QMS development includes:
- Quality manual and standard operating procedures (SOPs)
- Design controls and risk management procedures (ISO 14971)
- Complaint handling, adverse event reporting, and CAPA procedures
- Supplier qualification and management procedures
- Document and record control systems
We’ve helped clients across the US, Canada, UK, EU, and around the globe to develop quality systems that satisfy regulatory requirements and certification body expectations.
Internal Audits
Regular internal audits identify gaps before regulators or certification bodies find them. Our auditors evaluate your quality system implementation and assess compliance with FDA regulations, ISO 13485, EU MDR, EU IVDR, and MDSAP requirements.
Internal audit services:
- Full QMS audits covering all quality system elements
- Process-specific audits (design controls, CAPA, complaints, production)
- Detailed audit reports with findings and observations
- Follow-up audits to verify corrective actions
We approach audits as learning opportunities, creating an open and engaging environment. The goal is to help your team understand compliance requirements and improve processes, giving you confidence when regulators arrive.
Supplier Audits
Your suppliers’ quality systems impact your product quality and regulatory compliance. We conduct supplier qualification and evaluation audits to assess whether potential or existing suppliers meet your requirements.
Supplier audit services:
- Initial qualification and ongoing performance audits
- Audit reports with qualification recommendations
- On-site assessments at supplier facilities
- Corrective action follow-up
Our auditors evaluate compliance with ISO 13485, FDA regulations, and contract manufacturing requirements across all major jurisdictions.
Gap Assessments and Audit Preparation
Regulations and standards continuously change. Gap assessments identify where your quality system needs updating to maintain compliance or prepare for certifications.
Gap assessment services:
- ISO 13485:2016 gap analysis
- EU MDR and EU IVDR transition assessments
- MDSAP readiness evaluations
- FDA QSR/QMSR compliance reviews
- Pre-certification readiness assessments
We take a consultative approach to gap assessments, working with your team in an informal environment where questions are encouraged. You learn what needs fixing and why, preparing you for successful third-party audits and inspections.
Mock FDA Inspections
Mock inspections prepare your team for FDA inspections by identifying potential findings before regulators arrive.
Mock inspection services:
- Simulated inspections covering QSR/QMSR requirements
- Review of design history files, device master records, and quality records
- Assessment of CAPA effectiveness and complaint handling
- Management briefings on inspection readiness
Our auditors have extensive experience supporting companies through FDA inspections, knowing what inspectors look for and how to prepare your team.
Quality System Training
We provide customized training covering all quality system elements, customized to your products, operations, and regulatory requirements.
Training topics include:
- FDA QSR/QMSR and ISO 13485 requirements
- Design controls and design history file management
- Complaint handling and medical device reporting
- CAPA systems and root cause analysis
- Process validation and supplier management
- Risk management (ISO 14971)
Training is delivered on-site or remotely based on your preferences.
Additional Quality Management Services
FDA Inspection Support
We assist during actual FDA inspections, helping your team respond to inspector questions and document requests effectively.
Unique Device Identifier (UDI)
Support for UDI compliance including labeling requirements and database submissions.
Process Mapping
Visual documentation of your quality processes for training, gap identification, and process improvement.
Access Senior-Level Auditor Expertise
Each of our auditors bring 15-20+ years of med tech experience, including professional certifications, and conduct approximately 150 audit days annually across startups to multinationals. This gives us perspective on how quality systems work across company sizes, product types, and regulatory environments worldwide.
Why Choose AJW for Quality Management
Small to mid-size medical device and IVD companies often need experienced quality expertise to build, maintain, and audit compliant quality management systems. AJW provides senior-level quality professionals with hands-on experience across FDA requirements, ISO standards, EU MDR, EU IVDR, and MDSAP.
Customers gain practical quality leadership and audit readiness without expanding internal headcount.