Regulatory Consulting Services
Regulatory Expertise to Support Medical Device Total Product Life Cycle
CardioMed works with sponsors to translate company goals into clear regulatory strategies and achievable milestones, no matter the stage of medical device development or commercialization. Our consultants have specialized knowledge of the regulations, standards, and guidance applying to Class II and Class III cardiovascular devices, as well as first-hand experience with FDA review teams and processes.
Full-Spectrum Regulatory
Strategy & Execution
- Build comprehensive regulatory strategy covering device development, pre-market submissions, and FDA reviews
- Utilize FDA programs such as Breakthrough Device Designation and TPLC Advisory Program (TAP) to expedite pathway to market
- Prospective planning for regulatory milestones including IDE, PMA, 510(k), and global pathways
- Full project management of FDA submission packages: Breakthrough Device Designation, Pre-submissions, IDE, 510(k), PMA, HDE, and other types
- Drafting and preparation of regulatory documents
- Final review of regulatory documents or technical reports prior to submission
- Interpretation of applicable medical device regulations and guidance document requirements
- Assist with product labeling, IFU, and ICF drafting to ensure regulatory requirements are met
- Prepare cover letters and regulatory documents per known, expected formats and content
- Initiate, coordinate, and participate in meetings with FDA to discuss regulatory, scientific, and/or technical issues
- Direct-line relationships and long history of mutual respect with FDA Office of Cardiovascular Device Teams
- Literature reviews
- Manuscript drafting and white papers
- Focus clinical and scientific information to a safety, effectiveness, and risk-benefit perspective
- 510(k) Letter to File
- PMA Annual Reporting, 30-Day Notices, and Supplements
- Post-Approval Study Reports
- Assist with medical device import and export requirements
- Registration, listing, and reporting requirements
- Mock audits of domestic and foreign manufacturing sites
- Expert witness services
- Expert knowledge of regulations, standards, and guidance for Class II and III cardiovascular devices
- Close relationships with subject matter experts for specialized considerations
- Support for OUS regulatory authorizations alongside U.S. pathway strategies
The CardioMed Difference
Proactive engagement and execution tailored to your company's specific needs and regulatory phase — from startup to commercialization.
Deep understanding of FDA programs to expedite feedback and approval, including Breakthrough Device Designation and TAP.
Decades of productive FDA collaborations and regulatory knowledge, with direct relationships across cardiovascular device review teams.
Support at any stage of the Total Product Life Cycle: from pre-market strategy through post-market reporting and compliance.
Ready to Build Your
Regulatory Strategy?
Let CardioMed help you navigate FDA expectations with a clear, customized regulatory roadmap for your device program.
Schedule a Consultation