Quality Management
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 can implement a custom system for you, then train and support you to the point of passing your ISO 13485 certification audit.
Customized to each project, our “QMS-in-a-Box” ensures that your medical device can be presented for regulatory approval in any country in the world.
Contact us and find out how we can help you through your ISO 13485 certification.
What are ISO Standards?
The 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.
Services include:
- ISO 13485 and FDA compliant processes and documentation for all stages of your project including:
- policy and procedures
- forms
- logs checklists
- work instructions
- a “dry run” audit by a quality control expert prior to your certification audit