The Center for Medical Devices (CMeD) offers consultation services to researchers, companies, and inventors of medical devices who wish to seek advice, testing of their medical devices, and guidance on the path to regulatory approval. Available services include:
- Strategic planning and research needs for your medical device's approval.
- Clinical trial design and interpretation of data results about your device.
- Innovative design of feasibility, first-in-human, pivotal and post-market clinical research studies.
- Evaluation of medical devices for Humanitarian Use Designation, and design of Humanitarian Device Exemption studies.
- In-depth, up-to-date literature review of relevant medical devices in the field.
- Development of Objective Performance Criteria and Performance Goals for device trials.
- Safety monitoring and assessment of interim study results.
- Evaluation of clinical trial conduct and ethical concerns.
- Advice on data interpretation issues and international data concerns.
- Analysis and critical evaluation of final study data.
- Assistance with preparation of publications.
- Interface assistance with the FDA.
- Preparation of clinical trial study reports for the FDA.
- Assistance with preparation of responses to FDA for annual reports.
- Counsel for preparing FDA pre-submissions, IDE, 510(k), and PMA, HUD, and HDE submissions.
- Preparation for your meetings with the FDA.
- Instruction for how to prepare for FDA Advisory Panel meetings including:
- Panel strategy development.
- Mock panel practice and activities.
- Preparation of panel informational packets.
- PowerPoint presentation drafting.
- Assessment of preclinical device's engineering, potential clinical implications, and initial animal study data findings.
- Expert counsel on CMS regulations and reimbursement issues.
- Experienced CMeD faculty members available for your scientific advisory boards, executive committees, data monitoring committees, and clinical event committees.
- Advice for publishing study findings in key medical journals and medical meetings.
Center for Medical Devices
Mount Sinai Heart
Icahn School of Medicine at Mount Sinai
One Gustave L. Levy Place, Box 1028
New York, NY 10029-6574