Medical Device Experts
As medical device consultants, Beaufort, LLC, understands medical device regulation, the conduct of medical device clinical trials, and quality assurance within 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.
Beaufort provides a full range of regulatory consulting support services to U.S. and international clients in the medical device industry, including FDA 483 and warning letter resolution. With hundreds of PMA, IDE, CE-mark, and 510(k) submissions under our belt, Beaufort knows how to navigate the regulatory waters both in the U.S. and abroad.
For each type of submission, Beaufort can provide statistical support such as the development of statistical analysis plans (SAP) and sample size rationales, performing the analysis outlined in the SAP, and interpreting of the statistical results.
Around the world, Beaufort has a strong track record as a medical device CRO managing Phase I – 4 medical device clinical trials of Class II & III devices in multiple therapeutic areas. Our depth of experience, stability, flexibility, and our strong relationship with FDA mean that our medical device clients receive only tested, successful solutions.
Beaufort is committed to a customer-intimate quality systems and compliance model that is designed to deliver optimum performance and create a competitive advantage for our clients in the United States, Europe, Latin America, and the Asia-Pacific region. We cover all aspects of quality system audits, performance analysis, development, implementation, and compliance including FDA Quality System Regulations (QSRs), cGMP, ISO 13485 and more.
Medical Device Products
Beaufort has experience in medical device consulting for products in the following areas:
- Clinical Laboratory
- General Devices
- General Hospital
- Infection Control
- Obstetrical and Gynecological
- Ophthalmic, Ear, Nose and Throat
- Personal Use
- Physical Medicine
- Plastic Surgery
- Restorative Devices
- Software (stand-alone)
- Software (within device)
- Urology and Lithotripsy Devices