Medical Device Quality Consulting

Compliant Quality Management Systems
For Startups & Established Medical Device Companies

Medical Device Quality Management System Services

QA/RA makes sure you have an effective yet simple to operate quality management system. Your processes will be effective, compliant to the standards/laws that apply to you, and will minimize the impact on your staff to execute the processes.

A pre-production QMS is typically established during the feasibility stage of the design project, and includes document and records controls, design and development, risk management, software development, supplier selection and evaluation, and control of inspection and test equipment.

QA/RA Consulting Group can help you take a careful and phased approach to QMS development leading to a fully complete QMS that is established by the time the medical device is registered with the applicable regulatory authorities. We can help you ensure that it is maintained through continuous monitoring, internal quality audits and management review.

 

New Quality Management System Development

  • ISO 13485

  • ISO 9001

  • FDA QSR (21CFR820) and drug cGMP (21CFR210,211)

  • EU MDR, IVDR 

  • Canadian Medical Device Regulation-CMDR 

  • Cleanroom / Controlled Environment/Controls

  • Training

  • Audit representation

 

QMS Maintenance

  • Audit representation

  • Quality Management System gap assessments

  • Quality system change/transition planning as regulations change

  • Post Launch QMS Support

  • Training

  • Complaint Management / Adverse Event Reporting

  • Master File Maintenance

  • Tech Files / Design Dossier updates 

  • Post Market surveillance

 

Remediation

  • FDA Warning Letter / 483 Support

  • FDA Consent Decree Support

  • CE Mark reinstatement

 

Data Management Compliance

  • Data Integrity

  • eQMS implementation product leadership

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.