StarFish Medical

 StarFish Medical provides award-winning design, development, and flexible manufacturing outsourcing services —100% dedicated to the medical device and life science marketplace.  StarFish partners with innovative companies to create and manufacture breakthrough products for a full range of medical specialty areas including: Cardiovascular, Digital Health, IVD, Ophthalmology, Optics, and Ultrasound. StarFish expertise includes electronics, mechanical, human factors and software systems engineering.  Our proprietary Pathfinder™ process for medical device product definition saves clients time and resources throughout the technology and product development phases to commercialization. Prototype and low volume complex, electro-mechanical production are delivered in an ISO 13485 certified facility with FDA registration, including cleanroom capabilities. Regulatory and quality system (QMS) consultants at StarFish provide technical regulatory assistance for FDA and Health Canada submissions, including IEC 60601 and ISO13485.

Website: www.starfishmedical.com

Address: 455 Boleskine RD Victoria British Columbia V8Z 1E7 CA

Industry Role

Contract Design/Development/Manufacturing

Areas of Expertise

CardiovascularDisposablesOpthalmologyOrthopedicRespiratorySurgical

Product Lines

·         Innovative Development & Design

§  Electronics

§  Mechanical                                       

§  Human Factors

§  Software Engineering

§  Pathfinder™ process

§  Technology Commercialization 

·         Flexible Manufacturing

§  New Product Introductions

§  Custom, complex specialists

§  Supply chain management

§  North America facilities

§  Depot Repair & Field Service

§  Value engineering

§  Cleanroom

·         Regulatory and Quality Expertise

 

§  ISO 13485 certified facility

§  FDA registration

§  QMS audited by Client registrars:  UL, TÜV, BSI, VTT, CSA

§  QMS-in-a-Box solutions

§  Assistance for CE Mark, FDA and Health Canada submissions,  IEC 60601 and certification audits

 

 

Key Personnel

Scott Phillips, Founder and President

John Walmsley, VP of Product Development

Charles Garcia, VP of Business Development

Vesna Janic, Director of QA/RA

Henning Hueppe, Director of Finance

Jason Dolynny, Director of Manufacturing

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