The Clear Solution for Your Global Presence
We create one-of-a-kind strategies to achieve your Regulatory & Quality goals. Cogentsee’s regulatory strategy clients will have access to customized tactics for (1) new product development; (2) domestic and international registration; (3) field action management; (4) Merger & Acquisition strategies; (5) optimization of day to day RA/QA processes.
Establishing a controlled and well documented Regulatory and Quality Management System, that yields clean data, seamless & timely registrations and effective vendor management are key to a medical device manufacturer’s global advancement. Clients served by Cogentsee’s compliance support will have access to clear guidance around licensing and compliance maintenance activities at a domestic and international level.
Maintaining controlled, state of the art manufacturing, supplier, documentation & change control processes are among the critical components of an effective Quality Management System. We aim to ensure your company executes a high caliber QMS from start to finish. Clients served by Cogentsee’s quality assurance management team will have end-to-end audit, field action, & day to day quality management support.
Overseeing the allocation and distribution of knowledgeable resources is critical to a medical device company’s progression and expansion within a multinational market. Clients served by Cogentsee’s project management will deliver sustainable, customized oversight of key projects from their device’s inception through clearance, compliance and globalization.