“We know what the FDA’s expectations are because we interact with them so much. A lot of our value comes in just understanding that gray area of the regulations and what’s reasonable to expect the FDA to want. We can help you right-size it so that you’re balancing your regulatory risk with your costs and business timeline.”
–Chad Gibson, Managing Partner
CMD MedTech is a medical device regulatory consultant guiding companies through the complex regulatory landscape of medical device development and approval. Our experienced team provides comprehensive support for US FDA submissions and international regulatory requirements, ensuring efficient paths to market while maintaining compliance.
Why Work With CMD MedTech as Your Medical Device Regulatory Consultant
- Deep understanding of FDA expectations and unwritten requirements
- Several team members with RAPS RAC certifications
- Experience with multiple regulatory pathways and submissions
- Strong track record of successful regulatory submissions
- Expertise in managing regulatory communications
- Experience with US, EU, Canadian, and Australian/NZ markets
PRICING FOR OUR REGULATORY SERVICES
Our pricing is structured to accommodate various regulatory pathways and project needs. Our service offerings include fixed-price regulatory strategies and time-and-materials pricing for ongoing support. Contact us for a customized proposal based on your specific regulatory requirements.
5-Step Process for Getting Started With Medical Device Regulatory Strategy
Regulatory Pathways and Services
510(k) Submissions
- Most common pathway for medical devices
- Substantial equivalence demonstrations
- Complete submission preparation and management
Premarket Approval (PMA)
- Support for high-risk device submissions
- Clinical data evaluation and presentation
- Comprehensive regulatory documentation
De Novo Classification
- Guidance for novel low-risk devices
- Risk-benefit assessment development
- Complete submission management
Additional Services
Cybersecurity Compliance
We ensure your device meets the FDA’s cybersecurity requirements through all development phases.
Software Development Procedures
We help establish compliant software development processes meeting regulatory requirements.
Usability Engineering/Human Factors
We guide you through user research, testing, and documentation requirements.
Post-Market Support
We assist with ongoing compliance, including adverse event reporting and recall management.
FREQUENTLY ASKED QUESTIONS
We’ll help determine the most appropriate pathways through our regulatory strategy service, considering your device’s risk level, novelty, and intended use. We are an experienced medical device 510(k) consultant and have experience with other pathways for success.
We primarily support the US, EU, Canadian, and Australian/New Zealand markets, but we have experience in a broad range of other markets as well.
The timeline varies by pathway and market. We’ll provide detailed estimates based on your specific situation and help manage timelines effectively as part of our medical device regulatory services.
Yes, we can develop your initial regulatory strategy and then support you through the entire submission process, including pre-submissions, documentation preparation, 510(k) /De Novo submission, and other FDA communications.
We think an early, robust regulatory strategy is fundamental to a predictable product development timeline. We guide you through appropriate documentation and communication strategies, helping avoid common pitfalls that could delay your clearance or approval, or require additional work later.