Medical Product Lifecycle Management
Medical Product Lifecycle Management
Principal
Regulatory Affairs and
Quality Assurance
Associate
Regulatory Affairs and
Quality Assurance
Associate
Regulatory Affairs and
Quality Assurance
Rego Associates provides consulting services to the medical device industry.
We provide consultation on the overall medical product life-cycle management from product evaluation to market.
Establish and manage Quality Management Systems that are ISO, FDA, MDR (EU) and MDSAP compliant.
Medical device registrations, reporting, and support for US FDA, EU (CE Mark), and other international specific regulations and requirements.
Preparation of technical files, development of protocols and reports, technical assessments, position and white papers, gap analyses.
Take a look at Rego Associates' successful FDA Cleared Devices.
Please send us a message, email, or call us for an appointment.
Office: (949) 770-8710
Email: inquiry@regoassociates.com
25401 Cabot Road, Suite 122
Laguna Hills, CA 92653
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