“We’ve seen both great and poor quality systems, and we learn from that experience to help right-size yours. If you don’t do it right from the beginning, you waste time and money, so let us help you build the right foundation from the start.”
–Chad Gibson, Managing Partner
CMD MedTech provides comprehensive medical device quality system development and medical device quality services to ensure medical devices meet regulatory requirements while maintaining efficient operations. With decades of experience, our team helps companies efficiently establish, maintain, and improve quality systems that conform to FDA regulations and international standards.
Why Choose Us as Your Medical Device Quality System Consultant
- Extensive experience with successful quality systems, allowing us to implement best practices
- Full understanding of 21 CFR 820, the Quality System Management Regulation (QMSR), and ISO 13485
- Ability to right-size quality systems based on product risk and company needs
- Strategic approach that balances regulatory compliance with operational efficiency
- Experience across diverse product types and risk levels
- Proprietary Astro software platform for compliant electronic documentation
PRICING FOR OUR MEDICAL DEVICE QUALITY SYSTEM SERVICES
We offer both time-and-materials and fixed-price engagements tailored to your specific needs. Our quality system implementation offering typically takes 4-8 weeks, with pricing based on project scope and complexity. While our rates reflect our expertise, our efficiency and experience often result in long-term cost savings. Contact us to discuss your needs and receive a detailed proposal.
5-Step Process for Getting Started With Your Medical Device Quality System Needs
5-Step Process for Success With Your Medical Device Quality Management System
Additional Services We Offer
Document Control and Change Management
We help establish and maintain compliant processes for document revisions and approvals.
Internal Audit Support
We assist with planning and conducting internal quality system audits.
Management Review Facilitation
We help organize and conduct required management review meetings.
Quality System Maintenance
We provide ongoing support for system updates and improvements.
LDT Quality Systems
We help laboratories implement quality systems for laboratory developed tests for FDA compliance.
FREQUENTLY ASKED QUESTIONS
Yes, our Astro platform is fully compliant with applicable sections of the FDA’s electronic record and electronic signature requirements while remaining user-friendly and efficient. We provide additional materials (e.g., validation documentation) to help ensure your internal process is compliant with the regulation.
Typically 4-8 weeks, depending on scope and complexity. We focus on thorough implementation while maintaining efficiency.
We have experience across a wide range of medical devices, from low-risk to high-risk products, including mechanical, electro-mechanical, and software-based devices. If you have questions about our experience with a specific device, contact us.
Yes, our quality specialists can assist or lead a variety of quality efforts, including document control, Corrective and Preventative Action (CAPA) management, complaint handling, internal, external, and third-party audits, or training. We can help you integrate new processes into your quality system, like cybersecurity.