Quality Everywhere at TE
We design and manufacture components and finished devices that have a direct impact on the lives of patients around the world. Because of this, quality is a focus for TE Medical in everything we do.
Quality & Regulatory Compliance
We have a thorough understanding of the complex regulatory environment along with many of the facility and quality certifications and registrations to help support your needs. We host 100+ audits per year from customers and regulatory bodies across our global sites.
Certifications
Our certifications and registrations include:
- ISO 13485 and 14971 Risk Management Certified
- FDA Registered and compliant with the Quality System Regulation
- Class I, II, and III medical devices, including Premarket Approval (PMA) products
- Class 7 and Class 8 Cleanroom Controlled Environments
- US FDA 21 CFR Part 820 compliance
- Medical Device Single Audit Program (MDSAP)
Robust Global Quality System
TEOA (TE Operating Advantage) everywhere. Our TEOA enterprise-wide quality policy and program are designed to help ensure consistent high quality and compliance across our organization.
Quality systems
Dedicated on-site teams help ensure compliance with rigorous internal quality systems, some of which include:
- Supplier management
- Internal audit processes
- Validation strategy
- Design controls
- DHF-ready documentation
