Beaufort, LLC, is a medical device CRO that provides a full range of regulatory consulting support services to U.S. and international clients in the medical device industry.
From Europe to Asia, the Middle East to North America, top medical device companies around the world rely on Beaufort’s expertise as regulatory consultants. With hundreds of 510(k) submissions, PMA submissions, IDE and CE-mark submissions under our belt, Beaufort knows how to navigate the regulatory waters both in the U.S. and around the world.
Medical Device Regulatory Consulting Services
Our medical device regulatory consulting services include:
- Regulatory strategies
- Device classification
- Predicate device identification
- Pre-IDE submissions and meetings
- Protocol design
- IDE applications
- 510(k) submissions (traditional and special)
- De Novo submissions
- PMA and PMA supplement submissions
- FDA 483 letter responses
- Warning letter resolution
- Medical device reporting
- Liaise with FDA and European authorized representatives
- CE marking
- Annual reports
- Post-market support
For each type of medical device submission, Beaufort can provide statistical support including the development of statistical analysis plans (SAP) and sample size rationales, performing the analysis outlined in the SAP, and interpretation of the statistical results.
Medical Device Regulatory Experience
Beaufort’s medical device consultants have experience with products in the following therapeutic areas:
- Abdominal
- Anesthesiology
- Cardiovascular
- Clinical Laboratory
- Dental
- Gastroenterology
- General Devices
- General Hospital
- Hematology
- Infection Control
- Mammography
- Neurological
- Obstetrical and Gynecological
- Ophthalmic, Ear, Nose and Throat
- Orthopedics
- Personal Use
- Physical Medicine
- Plastic Surgery
- Radiological
- Reproductive
- Restorative Devices
- Software (stand-alone)
- Software (within device)
- Urology and Lithotripsy Devices
