For nearly two decades, Product Creation Studio has transformed ideas into meaningful products and experiences. Our ISO 13485:2016-compliant quality system, PCS+, ensures quality development standards are applied to each and every project.
We have deep expertise in medical device development and life science instrumentation. Our experience spans connected devices, home health, wearable technology, pharmaceutical delivery, point-of-care diagnostics, imaging and therapeutic ultrasound, photobiomodulation, and more.
Product Creation Studio’s designers and engineers operate with an entrepreneurial spirit and a constant eye on business strategy. We approach each effort with consideration for the project’s unique needs, leveraging our expertise to maximize client value.
Do the unknowns of function, science, or user interaction keep you up at night? Gain efficiencies and reduce risk with a phase zero exercise before comprehensive device development begins.
In Phase Zero, our team isolates and explores the risk area through selective research, analysis, experimental build, and test activities. We explore enough of the requirements and concepts to generate a feasible design. This focused process removes unknowns and empowers you with insight to make informed development decisions. Sleep better knowing that your most significant risks have been identified and mitigated, and you are positioned for comprehensive instrument development.
If your instrument requires medical device design control we can help. Our quality management system (QMS) is ISO 13485:2016-compliant or we can work within your system.
Our PCS+ Quality System enables us to:
Ensure no critical issues are overlooked
Reduce the risk of schedule delays, adoption barriers, product performance and patient safety
Meet global regulatory and customer requirements necessary to certify product design
Increase cost efficiency by identifying design challenges early
Improve time to market by establishing design processes and design transfer standards upfront
Enhance product safety and effectiveness
Accelerate the supplier selection process
Product Creation Studio is committed to underscoring our commitment to continuous improvement and excellence in product development for the healthcare industry.
We design products for compliance with recognized industry standards including but not limited to:
IEC 61010-1:2010+AMD1:2016
IEC 61326-1:2020
IEC 60601-1
IEC 60601-1-2
IEC 61326
UL 60950-1
We craft our support to meet your needs. Let us help you select the right project and team to outsource:
Project Management
Quality Engineering and Compliance
Ideation and Innovation
Usability Studies and User Research
UX and Industrial Design
Mechanical Engineering
Electrical Engineering
Software Engineering
Manufacturing Strategy and Support
