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Medical Device Consulting Services

Quality, Regulatory & Compliance
For Medical Devices, IVD & Combination Devices

Medical Device Compliance

QA/RA Consulting Group provides a comprehensive range of services in Quality, Regulatory Affairs, Product Development, and Human Factors / Usability for medical device and IVD companies.

From implementing quality management systems and developing regulatory strategies to conducting usability testing and preparing submissions, we are here to help you bring safe and effective medical devices to markets worldwide.

Regulatory Affairs

  • Global Regulatory Strategies 

  • Establishment Registration and Device Listing

  • FDA Warning Letter / 483 Support

  • PMA and 510(k) Submissions

  • FDA Consent Decree Support

  • CE Marking / European MDD / EU MDR Compliance and Transition

  • Post-Market Surveillance

  • U.S. Agent and Official Correspondent

  • Medical Device Initial Importer​

  • Post Launch Regulatory Support

  • Master File Preparation and Maintenance

Quality Management Systems

  • Global Quality System Development

  • ISO 13485 / ISO 9001 / FDA QSR / CMDR / EU MDR / GMP / CFR (Part 4 / 211 / 803 / 820) 

  • Quality Systems Gap Assessment

  • Sterilization Programs

  • Cleanroom / Controlled Environment 

  • Supplier Development / Management

  • Complaint and CAPA Best Practices

  • Process Validation

  • Configuration Management

  • Technical Writing

  • Pre-Certification Audits

  • MDSAP Mock Audits

  • QSIT

  • Internal Audits

  • Supplier Audits

  • Mock FDA Inspections

  • Product/Process Audits

  • System Audits

  • Desktop Audits

  • Contract Audits

  • Due Diligence

  • Temporary or "as needed" consulting for QMS compliance and regulatory affairs.

  • CAPA System Oversight and Management

  • Monitoring Key Performance Indicators

  • Quality System and other training as needed

  • Complaint Handling and Adverse Event Reporting

  • Document control and Configuration Management

  • Responding to FDA 483 Observations, Warning Letters and Notified Body audit findings.

  • Human Factors / Usability Engineering

  • New Product Launch / Early Life Cycle Planning

  • Design Controls / Design History File

  • Technical Documentation

  • Biocompatibility Assessment

  • Design Assurance / Verification and Validation

  • Safety Risk Management ISO 14971

  • Sterilization / Cleaning Process Strategy and Validation

  • US Agent Services

  • Initial Importer (DII)

  • Official Correspondent

Help From Start to Finish

To achieve milestones effectively, you need medical device consulting services at several checkpoints along the process. By hiring us you’ll save precious time and money along the way.

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