The goal of regulatory strategy is to provide you with a clear understanding of the types of regulatory and clinical trial requirements you will encounter in launching your medical device in the United States and internationally. Malca Chen-Zion will consider the current regulatory environment, relevant guidelines, and ongoing FDA and/or international medical device initiatives that could influence your regulatory pathway.
With Dr. Chen-Zion as your partner, you will gain a clear understanding of the regulations and requirements applicable to your medical device. Her expertise extends beyond what is available in published guidance documents and other materials.
Armed with her clearly defined strategy, your device will proceed smoothly along the appropriate pathway. Consequently, the cost and time needed to bring your innovation from bench to bedside will be reduced. And you'll more quickly and easily achieve your ultimate goal of bringing safe and effective medical technology where it is needed, to the market.
Regulatory strategy includes:
- Product Classification
- Intended use and indications for use strategy
- Survey of possible predicate devices
- Applicable standards and guidelines
List of requirements:
- Performance tests
- Biocompatibility testing
- Risk analysis
- Sterilization/Shelf life testing
- Pre-clinical/Bench testing
- Clinical trials requirements