As an ISO 13485 certified and FDA registered firm, we recognize the importance of regulatory compliance in medical device manufacturing. We share with our customers the commitment and responsibility for compliance with regulatory requirements throughout all regions in which their devices are marketed. Our systems are built with regulatory compliance in mind from design and development activities, to purchasing activities, through manufacturing and record archival. We strive to maintain a constant state of readiness for regulatory inspection by effectively executing our quality management system in all aspects of the business.
We partner with customers to generate and/or maintain:
- Design History Files
- Device Master Records
- Device History Records
- Post-Market Surveillance Reports
- Complaint Reporting
We also provide regulatory, design, and engineering services such as technical files, 510(k), animal studies, and clinical support. We are versed in sterilization management, product and process validation and verification, and biocompatibility requirements.