Services
Depending on the specific needs of your company and product device, our focus will be on:
- Establishing, updating, and maintaining QMS, Procedures, WI, Forms, and related documents
- Device clearances and approvals, i.e. FDA 510(k) Pre-market Notification
- Addressing non-compliance and implementing Corrective and Preventative Actions
- Conducting internal audits to monitor efficiency
- Auditing and evaluating suppliers
- Consultation including in-house training
