ISO 13485:2016 Certification - PCS+ Quality System

Committed to continuous improvement

As a leading medical device design firm, 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 PCS+ Quality System also benefits our work on consumer products and industrial equipment. 

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ISO 13485

The International Organization for Standardization (ISO) develops and publishes standards for quality management systems. 

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 system PCS+. 

ISO Importance

ISO standards ensure that products are safe, reliable and of good quality. An ISO quality system provides the highest standard of design by assuring every aspect of product design is addressed. 

International standards represent a massive consensus on organizational quality. The FDA, EU and Health Canada all require medical device development be managed by an ISO 13485 quality system to assure devices meet patient and regulatory requirements. 

This certification is a statement to the world that Product Creation Studio is committed to quality. It is also a strategic tool to help reduce costs by minimizing waste and errors while increasing productivity. 

PCS+ Quality Policy

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

PCS+ Quality Management Policy Benefits

  • Ensure no critical design 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 up front.

  • Accelerate the supplier selection process.

  • Enhance safety and effectiveness.

For more information, you can view our BSI Certificate of Registration