Having successfully produced and filed hundreds of PMA, IDE, CE mark and 510(k) submissions, Beaufort knows how to guide medical device development programs. Beginning with pilot studies, on to pivotal and post-surveillance, Beaufort is your full-service research partner. We’ve developed products across major and niche therapeutic indications and also have experience in combination product development.
Clinical and Regulatory Services
Beaufort provides complete clinical trial management services for medical device and combination product development. Starting with protocol design — whether it be composing new strategies or reviewing and optimizing existing plans — Beaufort will manage every facet of your research throughout the development spectrum. We’ll identify investigators and sites specifically for you geographic- and therapeutic-specific needs. We will appoint tried and true CRAs and perform comprehensive, yet efficient medical/safety monitoring. For each type of submission, Beaufort can provide statistical support, including the development of statistical analysis plans (SAP) and sample size rationales, analyses and presentation of the data is support of your marketing claims. We are experts in communicating with regulatory bodies and identifying how to best conduct research to support your product’s presentation to those regulatory bodies worldwide.
Our Medical Device Services Include:
- Regulatory strategy development
- Device classification
- Predicate device identification
- Intended use statement development
- Clinical protocol design
- Regulatory agency liaison
- FOI searches and requests
- Decisions tree analysis and guidance
- Post-market support
- Regulatory submissions
- Investigational Device Exemption (IDE)
- 510(k) Premarket Notification
- De Novo (Evaluation of Automatic Class III Designation)
- Premarket Approval Application (PMA)
- Request for Designation
Beaufort has developed devices across all risk classifications and is proficient in global regulatory standards, including FDA quality system regulations (QSRs), cGMP and ISO 13485. Beyond helping you design and execute a compliant medical device study, Beaufort offers a lineup of exceptional quality solutions. From quality system audits to production and process controls to supplier management, Beaufort’s services cover all aspects of quality assurance and compliance to help you successfully take a new product to market or maintain the quality of existing medical devices.
Whether you need to find one seasoned professional for a specific position or you need to staff an entire clinical team, trust Beaufort. We maintain an extensive global network (reaching 25+ countries) that comprises experienced clinical research associates (CRAs), medical monitors, regulatory affairs specialists, CRA managers, in-house CRAs and more. Not only can we help you build a qualified team of any scale, we can place specialists where you need them to get the localized expertise you need.
Beaufort will assign the experts you need to conduct research, support rigorous quality standards and guide region-specific regulatory strategies. With several staffing models — from functional outsourcing and staff augmentation to contract or permanent placement solutions — trust Beaufort to solve your staffing challenges.