All Medical Device Case Studies
Beaufort has provided regulatory strategy and compliance, clinical research and quality assurance services to established and emerging medical device companies. The following case studies describe specific solutions that we have tailor-made for clients that develop and manufacture medical devices.
A small, innovative US company requested regulatory support for submission of a 510(k) for a new medical device. The lack of internal expertise and infrastructure threatened this client’s ability to successfully achieve their business objectives. Beaufort was initially brought in for regulatory support, but as the project progressed, the client realized they needed assistance with clinical trial management as well. Beaufort created a collaborative environment to carry out the many responsibilities with the various partners in order to achieve the necessary results, including 510(k) clearance of this client’s medical device.
A company that offers comprehensive contract manufacturing services required regulatory support. The company needed a clear regulatory strategy for bringing their project to market in the shortest possible timeframe. In addition, the client needed clinical trial management and data entry to support a 510(k) submission to FDA. Beaufort provided ongoing regulatory consultation and conducted the clinical trials, including site identification/qualification, clinical study and regulatory document preparation, IRB submissions, site monitoring, and data entry in support of the company’s first 510(k) submission to FDA.
A large US manufacturer of medical devices, instrument systems, and reagents needed audits conducted at several clinical trial sites. The client sought assurance that clinical data was valid and could support a PMA submission. Lacking sufficient internal resources, the client selected Beaufort to conduct the assessments. Beaufort planned and audited two clinical sites and worked with the client to gain historical information regarding site staff and data collection. Beaufort recommended performing an audit of the Sponsor’s Trial Master File prior to auditing clinical sites, thus ensuring that the Sponsor held required regulatory documents for each site. Beaufort provided audit reports and held subsequent discussions with the client, enabling them to make informed decisions regarding the integrity of data associated with the clinical trial. The output of these audits provided the client assurance that their required study files were in order for potential FDA inspection following the submission of the PMA.
A small, direct-to-patient provider of wound supplies and compression therapy products needed assistance with an audit of their manufacturing supplier, as well as audits associated with an ongoing clinical trial. Beaufort conducted these audits on behalf of the company. They allowed the company to make informed decisions as a clinical trial sponsor. This client has since requested Beaufort’s additional support in developing a Quality System and assisting with their 510(k) submissions.
