Rego Associates

Rego AssociatesRego AssociatesRego Associates

Rego Associates

Rego AssociatesRego AssociatesRego Associates
  • Home
  • About
    • About Us
    • Albert Rego
    • Daniel B. Rego
    • Rogelio C. Rodriquez
  • What We Do
  • FDA Cleared Devices
  • More
    • Home
    • About
      • About Us
      • Albert Rego
      • Daniel B. Rego
      • Rogelio C. Rodriquez
    • What We Do
    • FDA Cleared Devices
  • Home
  • About
    • About Us
    • Albert Rego
    • Daniel B. Rego
    • Rogelio C. Rodriquez
  • What We Do
  • FDA Cleared Devices

What We Do

Rego Associates offers a variety of Regulatory Affairs, Quality Assurance, and Technical Expertise services to the medical device industry.


The following services are a partial list:

Quality Systems

  • Establish and Manage ISO 13485/FDA 21 CFR 820 QSR Quality Management Systems
  • Conduct ISO 13485 Training
  • Conduct Internal Quality Management Systems Audits
  • Develop Standard Operating Procedures in accordance to ISO 13485/FDA QSR/MDR 2017/745
  • Evaluate MDSAP and International Country Specific Quality System Requirements
  • Assess Design Control Procedures and Design History File development
  • Evaluate strategic and tactical Document Control processes

Regulatory Affairs

• Assess strategies for medical device regulatory submission pathways

• Evaluate United States and International country-specific regulations

• Evaluate medical device regulatory requirements

• Evaluate Medical Device Classification – United States and International

• Prepare US FDA Submissions

  • Pre-submission filing
  • PMA
  • de novo

• Prepare US FDA Registrations and Annual Reports

• Prepare EU Submissions

  • MDR 2017/745
  • Coordinate with Notified Bodies and EU Representatives

Technical Expertise

• Prepare Technical Files

• Develop Protocols and Reports in accordance to compliance

  • Clinical Evaluations
  • Post Market Activities (PMS, PMCF and PSUR)
  • Biocompatibility
  • Toxicology
  • Shelf-Life
  • Sterilization/Bioburden

• Perform Technical Assessments

  • Chemical
  • Engineering
  • Risk Analysis (ISO 14971)
  • Statistical Analysis

• Write Position Papers

  • Regulatory and Compliance interpretations
  • Scientific and Technical interpretations

• Perform Gap Analysis

  • Compliance standards version changes and interpretations
  • Regulatory changes and interpretations
  • Quality System changes and interpretations

Copyright © 2025 Rego Associates - All Rights Reserved.

  • Home
  • About Us
  • What We Do
  • FDA Cleared Devices

Powered by

This website uses cookies.

We use cookies to analyze website traffic and optimize your website experience. By accepting our use of cookies, your data will be aggregated with all other user data.

Accept