Quality Management

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.

 

Regulations

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

Quality Management - Regulations
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Quality Management

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

Documentation

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

Quality Management Manuals
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