C&E Consulting, Inc.

C&E Consulting is a Quality Systems / Regualtory Affairs consulting firm serving the medical device industry. We cater to start-up and small medical device firms and offer a full range of consulting and technical services including:

Quality Assurance

Quality System documentation
Packaging Validations
Failure Investigations
First Article Inspections (FAI)
Quality System Software Validation / Part 11
Supplier Audits

Regulatory Affairs

510(k) Preparation / Submission
Regulatory Compliance
Responses to Warning Letters

Please contact us to discuss your needs.

Craig Pagan

E-Mail: cpagan5@cfl.rr.com

Phone: (321) 409-8961

Privacy Statement