About Us
Regulatory Affairs and Quality Assurance
Rego Associates provides consulting services to the medical device industry. We particularly provide regulatory affairs and quality assurance services to our clients.
Innovative Solutions
From product development to post-market activities, Rego Associates supports clients with FDA medical device submissions of all types, including coordination of Pre-submission Meetings, Requests for Determinations, etc., CE Mark submissions (MDR 2017/745), and quality management systems (ISO 13485, FDA QSR).
Leaders in the Industry
Our expertise revolves around engineering, science, and medical device compliance management to conduct assessments, implement, and maintain product approval and post-market activities.