Candace F. Cederman, MS
Principal Consultant
Candace Cederman is a Principal Consultant at CardioMed Device Consultants with more than 30 years of experience in medical device regulatory affairs,…
Read bio →Regulatory Consulting
Regulatory strategy for every stage of the total product life cycle.
CMDC turns your company’s goals into a clear regulatory strategy with achievable milestones, whether your device is in early development, preparing for submission or already on the market. Our team of regulatory experts, including former FDA staff, brings deep knowledge of the regulations, standards and guidance that apply to Class II and Class III medical devices, and first-hand insight into how FDA review teams work.
Why CMDC
Regulatory advice that fits your device and your business.
Former FDA staff on your team
Our regulatory experts include former FDA staff, so we know how review teams think, what they'll ask and how to answer.
Strategy connected to evidence
Our regulatory, preclinical, clinical and quality consultants plan together, so your strategy and your evidence line up from the start.
A partner for the whole life cycle
The team that helps you get to market stays with you after approval, for supplements, reports and changes.
Our Capabilities
What our regulatory consultants do for you.
Pre-market regulatory strategy
A clear plan from device development to FDA decision, with milestones you can manage to.
- Regulatory pathway assessment
- Expedited programs, including Breakthrough Device Designation and TAP
- Evidence and milestone planning
Submissions and regulatory writing
Complete, well-organized submissions and documents, prepared or reviewed by people who know what reviewers look for.
- Submission package preparation and management
- Drafting and review of regulatory documents
- Labeling, IFU and informed consent support
Communications with FDA
Productive, well-prepared interactions with the agency at every stage.
- Pre-Submission (Q-Sub) packages and meeting preparation
- Leading or supporting FDA meetings
- Responses to FDA questions and deficiency letters
Scientific and academic support
The scientific evidence behind safety, effectiveness and benefit-risk arguments.
- Literature reviews
- Manuscripts and white papers
- Benefit-risk analysis
Post-market compliance
Support that continues after approval, for as long as your device is on the market.
- PMA annual reports, supplements and 30-day notices
- 510(k) letters to file and post-approval study reports
- Registration and listing, import and export support
- Mock audits of domestic and international sites
Specialist and international support
Additional expertise when your program needs it.
- Specialist collaborators for complex technologies
- Software, cybersecurity and electrical safety documentation for connected devices
- Support for regulatory authorizations outside the U.S.
- Expert witness services
SUBMISSIONS WE SUPPORT
From first meeting to post-market reporting.
Not sure which pathway fits your device? That's often the first question we answer.
- Pre-Submission (Q-Sub)
- Breakthrough Device Designation
- TAP
- IDE
- 510(k)
- De Novo
- PMA
- HDE
- PMA Supplements
- PMA Annual Reports
- 30-Day Notices
- 510(k) Letter to File
- Post-Approval Study Reports
- EU MDR
MEET SOME OF THE EXPERTS
The regulatory experts behind your program.
Elisa D. Harvey, DVM, PhD
Principal Consultant
Dr. Elisa Harvey is a Principal Consultant at CardioMed Device Consultants and a former FDA branch chief and regulatory program leader. She…
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H. Semih Oktay, PhD
Founder and Chief Regulatory Officer
Dr. Semih Oktay is the Founder and Chief Regulatory Officer of CardioMed Device Consultants, bringing more than 30 years of experience in…
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Kevin Soucy, PhD
Principal Consultant
Dr. Kevin Soucy is a Principal Consultant at CardioMed Device Consultants and former FDA Senior Lead Reviewer with seven years of FDA…
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Mona M. Advani, MS, MBA
Principal Consultant
Mona Advani is an accomplished medical device regulatory affairs consultant with more than 25 years of experience in U.S. and international regulatory…
Read bio →Ready to advance your device program?
Tell us about your device and timeline.