Quality & Regulatory Services
Quality Services That Enable Success
Our work doesn't end with ideation and design. We guide and support our medical device partners from Concept to ClinicalSM — to help our customers advance their medical device innovations efficiently and effectively.
With an on-site team committed to the highest quality systems and process standards, and deep expertise in navigating the complex regulatory environment, we offer a rigorous approach designed to move you from product design and development through clinical studies.
Additionally, we are ISO 13485:2003 registered through BSI, and feature a full quality system that also complies with FDA's 21 CFR Part 820. We are also ISO 14971 Certified to Risk Management.
- Customization of a quality system to meet your specific needs and business objectives
- Development of procedures and processes to support your project
- Regulatory submission support, including drafting of submissions
- Oversight and ongoing support of your contract sterilization vendors
- Programs for biocompatibility and sterility testing
- Document control through the Document Change Order process
- Completed documentation packages, including:
- Design History Files
- Device Master Records
- Pre-market Approval Documents