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KEY ISSUES
GLOBAL REGULATORY STRATEGY
Identification of regulatory requirements in target countries and exploration of initial approach options
PREMARKET SUBMISSION CONSIDERATIONS
Determination of the probable regulatory submission path (IDE/510k/PMA/Design Dossier/Technical File)
CLINICAL TRIAL CONSIDERATIONS
Determination of likely trial requirements to support regulatory submissions, exploration of appropriate clinical endpoints, designation of need for pilot and pivotal studies
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You have a great idea for a new medical device - what should you be thinking about at such an early part of the process? Many of the decisions you make at this stage can have a tremendous impact on your project. By anticipating the regulatory requirements associated with your new product now, you can address questions that will improve its chances of successfully being approved or cleared.
MDCI can help you by developing and implementing product-specific regulatory strategies for both local and worldwide product introductions. Specifically, we can:
- Assess impact of regulatory environment and FDA policies
- Assess applicable Medical Device Directives and individual country requirements
- Determine product classification and essential requirements
- Design pre-clinical and clinical studies
- Evaluate technical and clinical data, including labeling reviews and risk management determinations
- Communicate and meet with FDA
- Provide liaison with Notified Bodies and Competent Authorities
- Assist in determining FDA Center jurisdiction for biotech and combination products
Speak with a Consultant
Reach our Massachusetts office at 1-508-643-0434, Monday through Friday, 9:00 a.m. to 5:00 p.m. Eastern. Or click here and a consultant will contact you directly.
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© 2004 Medical Device Consultants, Inc. All rights reserved.
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