Regulatory Strategy and Compliance
A sound regulatory strategy provides a foundation for successful healthcare innovation within companies that design and manufacture medical devices and combination products. Beaufort is here to help you develop and implement customized regulatory strategies designed to optimize the development of your medical device products.
Our regulatory services for medical device companies include:
- Regulatory strategy development
- Device classification
- Predicate device identification
- Protocol and study design development
- Statistical Analysis Plan
- Representation before regulatory bodies
- Preparation for and conduct of meetings with regulatory bodies
- Pre-IDE meeting preparation (scheduling, information package development, presentation assistance, and FDA mediation)
- Statistical programming and data analysis
- Preparation of pre-market submissions: IDE, PMA, and 510(k)
- Device Master Files
- Labeling and advertising review
- Continuing FDA liaison
- Warning Letter resolution
- EU experience
- Regulatory training
Review case studies regarding Beaufort’s regulatory strategy and compliance services for medical device manufacturers.
