Quality
Arterex Trusted Quality
Comprehensive Systems, Capable Expertise, Collaborative Development, and Practical Application of Quality Principles
Our Comprehensive Quality Systems are compliant to the highest global industry standards for design and manufacturing of medical devices and therapy systems.
- Registered facilities with the US Food and Drug Administration; compliant to FDA 21 CFR Part 820 (QSR)
- ISO 13485:2016 Medical devices: Quality management systems and associated standards
- Compliance with EU MDR: European Union Medical Device Regulation
These Quality Systems are fully integrated into our medical device design, new product introduction, regulatory affairs, manufacturing, and distribution platforms.
With Capable Expertise we provide product development, implementation, and ongoing quality surveillance for Class I, Class II, and Class III medical devices and systems.
- Development and submission of 510k premarket notifications
- High risk device development, clinical trials, and PMA submissions
- Creation of Device Master Records and Technical Files
- Construction of Risk Management plans for products and processes
- Product Life Cycle development
- Post Market Surveillance
- Clinical Evaluations
Partnering in Collaborative Development, we navigate the complexities of product development and/or new product introduction utilizing our system processes and customer requirements. Device development and introduction is accelerated through phase gate reviews and approvals providing constructive feedback and problem solving opportunities.
- Design for Manufacturability
- Product Verification and Process Validations
- Manufacturing Standards
- Process Control Plans
- Product Acceptance Standards
- MSA Measurement Systems Analysis
Arterex believes in the Practical Application of Quality Principles. We organize the breadth of medical device development and manufacturing regulations into practical, disciplined procedures/routines to produce high-quality products within a highly regulated environment through:
- Workforce Training to Quality Applications
- Employing Lean Manufacturing Concepts
- Utilizing Quality at the Source
- Quality System Auditing
- Continuous Improvement through Corrective and Preventive Actions (CAPA)
- Risk Plan Revision
- Supplier Quality Management
- Quality System Oversite by Management Review
View our ISO Certificates
