High Quality, Safe and Certified Medical Devices
If you are not yet certified to complete the design, development, manufacture and delivery of your medical device, StarFish offers a complete "QMS-in-a-Box" process. We will implement a custom system for you, train you and support you to the point of passing your ISO 13485 certification audit
StarFish "QMS-in-a-Box" includes:
- ISO 13485 and FDA compliant processes and documentation for all stages of your project, including:
- Policy and Procedures
- Logs Checklists
- Work Instructions
- An audit dry run by a quality control expert prior to your ISO 13485 certification audit.
Customized to each project, "QMS-in-a-Box" ensures that your medical device can be presented for regulatory approval in any country in the world.
What are ISO Standards?
The worldwide International Organization for Standardization (ISO) was established to create international standards in many areas. ISO 9000 is a set of standards for management focused on meeting customer expectations.
Medical device manufacturers are subject to the ISO 13485 variant of this standard that is specific to the design, development, manufacture and delivery of medical devices. All medical devices require a Quality Management System (QMS) in order to satisfy regulatory requirements for manufacture and sale. All StarFish projects are compliant with this standard.