Quality Management System
It is the policy of Cadence, Inc. to provide products and services that meet or exceed our customers’ quality expectations, legal and regulatory requirements, and compliance with standards.
Cadence is committed to complying with requirements, and to maintaining the effectiveness of the Quality Management System (QMS) through continuous improvement.
Our quality control processes ensure compliance with industry standards and regulations:
ISO 13485 Certification
- Cadence adheres to the highest Quality Management Standards (QMS) for medical and drug delivery devices.
- Process Validation (IQ/OQ/PQ): Complete validation services, including process development, PFMEA, Measurement Systems, along with comprehensive testing to validate process performance and repeatability.
Process Validation (IQ/OQ/PQ)
Complete validation services, including:
- Process development
- PFMEA
- Measurement Systems, along with comprehensive testing to validate process performance and repeatability.
Regulatory Compliance
We operate CFR 21 Part 820 FDA registered facilities (PA, VA, Costa Rica, RI, WI); all facilities are cGMP compliant.
Sterilization Management
Cadence works with our OEM partners to identify the best sterilization method for your product while managing the process with a contract sterilization provider.
Sterilization Management
Our dedicated facility also contains a Certified ISO Class 7 (10,000) Cleanroom for the most extreme final assembly requirements.
Our experienced team and robust quality systems stand ready to help in the final stages of your new product development process, including the critical management of the sterilization process.
Contact us for all of your sterilization management needs.
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