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, training, 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.