Product development and patient safety begins and ends with quality management. Our team can develop a Quality Management System or improve your existing system, partnering with you to maintain compliance.
We help clients achieve and maintain compliance with regulations.
We partner with clients to advise effective Quality Assurance (QA) management
We help implement Quality Management Systems
We can provide emergency response to compliance risks (CAPAs, complaints, eMDR procedures, non-conforming product)
We can help with audit response and resolving audit findings
We can help with FDA warnings and interactions
We help clients implement a Quality Management System.
Establishing a Quality Management System is a requirement for medical device manufacturing.
Establishing a QMS shows that your organization is committed to Customer Satisfaction and Continuous Improvement
We help with the selection and the build of the QMS
We help integrate regulatory and quality strategies using risk-based approaches
We specialize in ISO 13485:2016, 21 CFR 820, and ISO 9001:2015
We help clients with Quality Documentation.
We help write Quality Manuals, Procedures, forms, and work instructions
We help clients with document control, retention, and archiving
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