Medical Device Qualified Supplier Directory
StarFish Medical Company Profile
Qualifications: ISO 13485, FDA Registered
Markets Supplied: North America
StarFish is a leading Medical Device service provider of design, development, and manufacturing services. We partner with innovative companies to create and manufacture breakthrough products for a full range of medical specialty areas including Digital Health, Microfluidics, and Ultrasound.
We use our proprietary PathFinder™ process for medical device product definition, technical engineering and product development Our prototype and volume production are delivered in an ISO 13485 certified facility with FDA registration.
Our ISO 13485 consultants provide technical regulatory assistance for FDA and Health Canada submissions (including IEC 60601). And our QMS-in-a-Box solutions deliver an effective and affordable Quality Management System that establishes a clear commitment to medical device regulatory compliance for client companies.
Medical Device Design and Development
StarFish Medical has been designing, developing and manufacturing world class medical devices for entrepreneurial companies and entrepreneurs since 1995. StarFish Medical specializes in electro-mechanical devices, diagnostic and imaging equipment. We have unique expertise in a broad range of areas including Digital Health, Ultrasound, and Microfluidics. We free our clients of the engineering and operations issues so they can focus on other tasks such as finance, distribution and sales. We also help them find the right answers to the right questions during the early stages of prototyping and design all the way through regulatory approval and manufacture.
Medical Device Manufacturing for Low Volume, High Complexity
Our facility specializes in low to medium volume production of electromechanical medical devices. A full service medical device manufacturer, we also pilot production for new product introduction (NPI) and higher volumes. We manufacture medical devices for sale in Canada, the USA, the EU and the Far East. Our facility is certified to ISO 13485 and is compliant with the FDA Quality System Regulation (CFR 820). Regular audits and factory inspections by CSA ensure our quality system consistently produces high quality products. A Class 100,000 Clean Room with capabilities up to class 10,000 is part of our range of expanded facilities for laboratory and product customization. The clean room allows a wider range of testing services, custom prototypes requiring a clean room manufacturing environment, and higher volume medical disposables.
Technical Regulatory Support & QMS-In-A-Box
The FDA, Health Canada, and other government authorities carefully regulate the development, manufacturing, marketing and sales of medical devices. It is a complex area requiring expert knowledge and experience. Our ISO 13485 consultants have guided many companies through this approval process. Their expertise and experience can help you navigate the regulatory hurdles and comply with all standards that apply in your markets.
QMS-in-a-Box helps you ensure regulatory compliance via process control, design control, retention of records, accountability, traceability and more. All for fraction of the time and cost of building your own Quality Management System from scratch. StarFish Medical can customize your QMS-in-a-Box, then train and support you to pass ISO 13485 certification audit.