top of page

Medical Device Consulting Services

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

Medical Device Compliance

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

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

  • Certification Audits

  • MDSAP

  • 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.

  • 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.

  • 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.

  • 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

  • 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

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.

bottom of page