• 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

  • RoHS Compliance

Comprehensive Service Offerings Throughout the Product Life Cycle

How Can We Assist You?

Your Global Medical Device Compliance Partner

QA/RA Consulting Group offers a wide range of Quality, Regulatory Affairs, Product Development, and Human Factors / Usability services to medical device and IVD companies.

From quality management system implementation, regulatory strategies, to usability testing and submissions, we can help you bring a safe and effective medical device to markets around the world. 

Regulatory Affairs

  • Regulatory Strategies 

  • Medical Device Applications and Registration, and Device Listings

  • FDA Warning Letter / 483 Support

  • 510(k) Pre-Market Notifications

  • Sterilization Tech File Support

  • FDA Consent Decree Support

  • CE Marking / European MDD / EU MDR Compliance

  • Complaint Management / Adverse Event Reporting

  • Post-Market Surveillance

  • U.S. Designated Agent for Foreign Manufacturers

  • Post Launch Regulatory Support

  • Master File Preparation and Maintenance

Audit Services

  • Certification Audits

  • MDSAP

  • QSIT

  • Internal Audits

  • Supplier Audits

  • Mock FDA Inspections

  • Product/Process Audits

  • System Audits

  • Desktop Audits

  • Contract Audits

  • Due Diligence

US Agent Services

  • Assist FDA in communication with the foreign manufacturer/ establishment.

  • Respond to questions from the FDA regarding the foreign establishment’s devices that are offered for import into the US.

  • Assist FDA in scheduling inspections of the foreign manufacturer.

  • Initial Registration of a new Establishment via the on-line FDA Unified Registration and Listing System (FURLS).

  • Facilitate processing of Client’s payment of the FDA Establishment Registration Fee (annual requirement)

  • Initial Listing of medical devices that will be imported into and marketed in the US.

  • Update the on-line Registration and Listing records annually as required by FDA and as needed.

  • Provide an importation letter template, as requested, to facilitate importation.

  • Provide notifications and updates from the FDA regarding changes to the Registration and Listing requirements.

Quality Management Systems

  • Global Quality System Development

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

  • Sterilization Programs - Ethylene Oxide / Radiation / Steam / Aseptic Fill

  • Cleanroom / Controlled Environment Particulate / Bioburden / Cleaning / Employee Controls

  • Quality Systems Gap Assessment

  • Best Practices / Process Re-engineering

  • Supplier Development / Management

  • Process Validation

  • Technical Writing

QA / RA Outsourcing

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

  • Internal and Supplier Quality Audits

  • CAPA System Oversight and Management

  • Monitoring quality metrics and key performance indicators for
    Management Review

  • Quality System and other training as needed

  • Complaint Handling and Adverse Event Reporting

  • Document control and maintenance of the quality system.

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

Design & Development

  • 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

  • RoHS Compliance

Initial Importer Services

  • Facilitate the marketing of devices (Class I, II) from a foreign manufacturer to the person who makes final delivery or sale

  • Report adverse events (under 21 CFR 803 Medical Device Reporting (MDR) regulations), specific malfunctions, Corrections and Removals, and Medical Device Tracking (if applicable)

  • Maintain MDR event file for each adverse event

  • Forward received product complaints to manufacturer

89426bd2c9661d84b05465e5e135c002.png

Copyright © 2021 QA/RA Consulting Group, Inc. ​All Rights Reserved

  • Twitter - Grey Circle
  • LinkedIn - Grey Circle
  • Facebook - Grey Circle

Follow Us on Twitter

Follow Us on LinkedIn

Follow Us on Facebook