Stephen Page founded MedReg Associates in 2004 after 17 years in the medical device industry. For the last 20 years, companies at the forefront of innovation have trusted MedReg as a partner in navigating their most critical compliance demands. MedReg provides full spectrum regulatory and quality consulting to startups and Fortune 500 companies.

 
 
 

  • 510(k) Premarket Notifications

  • PMA Submissions

  • CE Marking

  • Company Registration and Device Listing

  • Quality Systems: ISO 13485 and FDA Quality System Regulation

  • Design Control

  • Supplier Management

  • Risk Management

  • FDA, Internal and Supplier Audits

  • Due Diligence

  • Validations

  • International go-to-market in USA

  • Corrective and Preventive Actions

  • Wide Range of Device Experience

    • Single-use Disposables

    • Reusables

    • Implants

    • Software Driven Devices

    • Lasers

    • Orthopedics

    • Ophthalmic

    • Catheters

    • Novel Technologies

 

Trusted quality & regulatory partner for 30 years.