“We know how to build quality systems right the first time. Our decades of experience have refined our approach to quality system development, and we’ve built best practices that consistently deliver compliant, efficient systems. We help you avoid the common mistakes that lead to costly rework later.”
–Micki Conklin, Senior Quality & Regulatory Specialist
CMD MedTech provides comprehensive medical device quality system development and implementation services to ensure medical devices meet FDA regulations and international standards. The FDA requires medical device manufacturers to have a quality system in place before marketing their devices–these requirements ensure device safety and effectiveness through documented processes. With decades of experience, our team helps companies efficiently establish quality systems that are right-sized for their specific needs—from initial development through ongoing management—ensuring compliance without unnecessary complexity.
Why Choose CMD MedTech as Your FDA Quality System Consultant
- Right-sized approach based on your device classification, activities, and business needs—not one-size-fits-all templates
- Customization expertise to tailor quality systems to your specific processes, outsourcing arrangements, and organizational structure
- Full lifecycle support from initial quality system creation through implementation, training, and ongoing management
- Understanding of both FDA expectations and international requirements (ISO 13485)
- Integration with development processes so quality requirements align with your design and regulatory timelines
- Flexibility in engagement models from development-only to full quality system management services
Pricing for Quality System Development
Our quality system development services are customized based on your device classification, the activities you perform in-house versus outsource, and the level of support you need. We offer flexible engagement models, including fixed-price quality system development, time-and-materials implementation support, and ongoing management services. Contact us to discuss your specific needs and receive a detailed proposal.
5-Step Process for Quality System Development and Implementation
Additional Services We Provide
Medical Device Quality Services
Explore our full range of quality consulting, audits, and compliance support beyond quality system development.
Medical Device Regulatory Services
We help navigate FDA submissions and regulatory pathways that require quality system documentation.
Medical Device Engineering
Our engineering team ensures quality requirements are integrated throughout your product development process.
Quality System Management
For more complex devices or companies not ready to hire full-time quality staff, we can manage your quality system by:
- Handling all documentation and form completion
- Managing Corrective and Preventive Actions (CAPAs), complaints, and non-conformances
- Conducting management reviews and internal audits
- Serving as your fractional quality department (typically quarter-time to part-time)
- Operating more efficiently because we’re managing our own quality system design
Frequently Asked Questions About Medical Device Quality System Development
Timing depends on your device classification and development stage:
- Class II/III devices should implement quality systems during design and development to avoid redoing documentation later, since the FDA requires design controls to be performed under a quality system.
- Early-stage companies can work under CMD’s quality system or a partner’s system until you’re closer to market and more certain your device will succeed.
- Class I devices typically don’t need a quality system until right before market entry, since they often have minimal requirements.
As your FDA quality system consultant, we prioritize your business success over maximizing our revenue—we’ll tell you honestly when you don’t need to invest yet, helping you avoid unnecessary expenses while your technology and market viability are still uncertain.
The timeline varies based on device complexity and scope. Because of our extensive industry experience, we’re able to focus collaboration time on customization rather than starting from scratch. The timeline also depends on your responsiveness to company-specific inputs, such as quality policies and approval structures.
If you are going to market with a Class I device or developing a Class II or III device and you don’t yet have an FDA compliant quality management system in place, you need quality system development. This service creates the complete framework that defines how you’ll comply with FDA requirements. A quality system includes management processes (like document control and management reviews), design and development controls, production processes, and post-market procedures (like complaint handling and CAPAs).
We can work with existing templates, but we’ve found this is less efficient. Systems created by others often don’t follow best practices we’ve learned through experience, requiring us to spend extra time understanding unfamiliar structures. If you want us to manage your quality system long-term, it’s most efficient if we create it using our proven approach.
Template packages give you documents but not the expertise to customize them properly. Many companies don’t realize templates need significant tailoring based on device classification, activities performed, and organizational structure. We provide the “how” along with the “what”—ensuring your system actually works for your specific situation rather than just checking a compliance box.
Yes, our quality system development meets both FDA regulations and ISO 13485 international standards. Some countries have additional specific requirements, which we can address as needed.
FDA inspectors will review your quality system procedures, ask to see documentation logs (like CAPA logs or management reviews from specific years), and examine examples of completed records. They verify you’re following your own procedures and maintaining required records. CMD MedTech prepares systems that make inspections straightforward by ensuring documentation and processes align with FDA expectations and records are easily retrievable.
Yes, training is typically part of our quality system implementation for medical devices. We offer train-the-trainer sessions (efficient for smaller teams) or department-specific training (for larger organizations). Training covers when to use each process and how to complete forms, ensuring your team can execute the system independently.
Operating without a required quality system or failing to maintain compliance puts your business at significant risk. The FDA can issue warning letters that damage your reputation and require costly corrective actions. More seriously, they can mandate product recalls, halt your manufacturing operations, or pull your device from the market entirely—actions that can be financially devastating for a company. Beyond regulatory consequences, inadequate quality systems can harm patients through device failures, which also exposes your organization to significant liability. While it may seem like an administrative burden, a properly implemented quality system protects both your patients and your business investment.