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…
Read bio →Clinical Trial Consulting
Clinical strategy and oversight for Class II and Class III medical devices.
CMDC helps you design clinical programs that answer FDA’s questions, and makes sure they’re carried out well. From study design and protocols to vendor oversight and audit readiness, our clinical experts work alongside your team at every stage.
How we can help
PLANNING A STUDY
Design your clinical strategy
We shape your study design, endpoints and protocol around your regulatory pathway, so the data you collect is the data FDA needs.
STUDY UNDER WAY
Keep your trial on track
We can help managing your CROs, vendors and sites day to day, so problems surface early and your study stays on schedule.
INSPECTION OR SUBMISSION AHEAD
Get audit-ready
We audit sites, check GCP compliance and run mock inspections, so your clinical data stands up to FDA scrutiny.
Why CMDC
Clinical programs built to support approval.
Clinical and regulatory strategy aligned
Our clinical and regulatory experts plan together, from EFS to pivotal IDE trial, so your study answers the questions FDA will ask.
On your side with vendors
As consultants rather than a CRO, we help you choose the right partners and hold them accountable for quality and timelines.
High-risk device experience
Implantable, interventional and Class III technologies, where study design and documentation have to be right.
Our Capabilities
What we do for you.
Clinical strategy and trial design
A clinical plan built around your regulatory pathway.
- Clinical strategy for IDE, PMA, 510(k) and international pathways
- Study design and endpoint selection
- Statistical considerations
- Protocol development and study planning
Vendor selection and oversight
The right CROs and vendors, held to the right standard.
- Identifying and qualifying CROs and vendors
- RFPs, bid evaluation and contracting support
- Ongoing oversight of quality and timelines
Medical and regulatory writing
Clear, compliant clinical documents.
- Clinical protocols and amendments
- Informed consent forms
- Adverse event narratives
Clinical evidence and evaluation
The clinical evidence behind your submission.
- Clinical evaluation reports
- Literature reviews and critical appraisal
- Clinical evidence strategy for submissions
Clinical program management
Coordination across sites, vendors and countries.
- Project management for U.S. and international studies
- Coordination of sites and vendors
- Timeline, risk and milestone management
Audit readiness and GCP compliance
Clinical data and processes that hold up to inspection.
- Clinical site audits
- GCP compliance assessments
- Mock audits
- FDA and international inspection readiness
STUDIES WE SUPPORT
From first study to pivotal trial.
Not sure what clinical data your device needs? That's often the first question we answer.
- IDE studies
- Early feasibility studies
- Pivotal trials
- Clinical data for PMA and 510(k)
- International studies
- Post-approval studies
- Clinical evaluation reports
- GCP
- ISO 14155
- Site audits
- Mock inspections
Trusted network
We know the CROs and specialists who do clinical execution, data management and biostatistics well, and recommend the ones that fit your study, budget and timeline. Then we stay involved, overseeing their work on your behalf.
Meet the experts
The experts behind your program.
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…
Read bio →Lisa Bellincampi, PhD
Affiliate Consultant
Dr. Lisa Bellincampi is an Affiliate Consultant with CardioMed Device Consultants, bringing about 20 years of experience in research and development and…
Read bio →
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 →
Richard E. Galgon, MD, MS
Principal Consultant
Dr. Rick Galgon is a Principal Consultant at CardioMed Device Consultants, bringing extensive expertise in medical device regulatory affairs, biomedical engineering, clinical…
Read bio →Victor Novack, MD, PhD
Affiliate Consultant
Dr. Novack is a Physician Trialist at CardioMed Device Consultants. In addition, he is currently the Head of The Clinical Research Center,…
Read bio →Ready to advance your device program?
Tell us about your device and timeline.