Cutting edge
Medical devices

Developing new medical innovations

For nearly two decades, Product Creation Studio has transformed ideas into meaningful products and experiences. Our ISO 13485:2016-certified 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.  

 

 

 

 

 
Medical-Banner.png

PCS+ Quality Management System
Consistently delivering high quality 

As a leader in medical device product development, Product Creation Studio adopted ISO 13485:2016 Certification to underscore our commitment to continuous improvement and excellence in product development for the healthcare industry.

Our quality system also benefits our work on consumer products and industrial equipment.

What is ISO 13485?

ISO 13485 represents the requirements for a comprehensive quality management system for the design and manufacture of medical devices. The latest update to the standard was released in 2016 and is intended for use by companies involved with the design and production of medical devices. Product Creation Studio has named our quality system PCS+.

PCS+ Quality Policy

We continually improve our processes to provide meaningful and inspired design and engineering solutions that meet or exceed our client and regulatory requirements.

Our PCS+ Quality Policy 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