Since 2002, we have provided biomedical engineering services and solutions to medical device manufacturing clients. Specifically, we offer technical document remediation and engineering services in five key areas: regulatory compliance, process validation, risk management, design control, and post market support. Our balanced team approach is comprised of a cohesive team of appropriately-trained engineering experts that mobilize as a single unit in order to achieve a common objective. This approach to client projects differentiates us from our competitors and we've had great success in providing team-based solutions to FDA enforcement actions, such as remediating Form 483 and Warning Letter observations. Mission: To help improve, prolong and save patient lives by providing regulatory compliance, and quality engineering services to medical device manufacturers, resulting in products that meet rigorous industry and quality standards.
51 to 200
TypeCompany - Private
RevenueUnknown / Non-Applicable
IndustryBiotech & Pharmaceuticals
CompetitorsUnknown
Founded2002