Our Services

Quality Management

High Quality, Safe and Certified Medical Devices

We specialize in medical device quality assurance. If you are not yet certified to complete the design, development, manufacture and delivery of your medical device, or need help with the FDA approval process for medical devices, StarFish can implement a custom system for you, then train and support you to the point of passing your ISO 13485 certification audit.

We also provide insights regarding IEC60601 Edition 3.

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.

 

 

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

 

QMS Consultation

 

The cost of creating a QMS is substantial for a small company like Clearwater. We definitely got great value. Our work with StarFish Medical enabled us to pass the ISO 13485 inspection and set up our QMS before hiring a full-time quality person.

Matthew Bromwich MD, FRCSC, BSc.
Chief Executive Officer
Clearwater Clinical

I am extremely happy with StarFish support while setting up a QMS for Otoharmonics and the Levo System tinnitus sound therapy device. I’ve worked with a lot of QMS people in my life and the StarFish team are the most helpful and easy to work with.

Their knowledge is outstanding; A lot of other QA people simply pretend to know regulatory details and implications while the StarFish team really does. And they are not afraid to admit when additional research is needed.

Michael Baker
President & CEO
Otoharmonics Corporation