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Product Creation Studio Awarded ISO 13485:2016 Certification

Thursday, March 30, 2017   (0 Comments)
Posted by: Colleen Toomey
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Product Creation Studio Awarded ISO 13485:2016 Certification


Product Design and Development Firm Announces PCS+ Quality System to Offer Superior Development Services to Clients



SEATTLE, March 29, 2017 (GLOBE NEWSWIRE) -- Product Creation Studio, a Seattle, Washington-based product design and development firm, is pleased to announce that it has been awarded ISO 13485:2016 certification, the internationally-recognized quality standard for medical devices.


As a leading medical device design firm, Product Creation Studio adopted ISO 13485:2016 certification to underscore the company’s commitment to continuous improvement and excellence in product development for the healthcare industry. The recognized quality management system dedicated to design and verification of medical products is a component of a more comprehensive business quality system called PCS+.


“Product Creation Studio is committed to high-quality development services,” Cameron Smith, CEO, Product Creation Studio said. “We have worked diligently to ensure that our custom quality system, PCS+, meets or exceeds the standards required. We apply our system to each and every effort, whether designing a medical device, consumer-facing hardware or an industrial product. Our quality standards help our clients deliver the safest and most effective products to market.”


The certification is the result of an extensive assessment performed by BSI Group and confirms that Product Creation Studio’s quality management system has been effectively implemented to the requirements of ISO 13485. 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. 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 recognize the ISO 13485:2016 standard as a preferred means to meet their requirements for quality management of medical device development. Learn more about Product Creation Studio’s quality policy and benefits.


About Product Creation Studio


Product Creation Studio: Designing Products for Positive Impact For nearly two decades, Product Creation Studio has fostered innovation and transformed ideas into meaningful products and experiences. With expertise in developing consumer, medical and industrial products, our team is trusted by some of the world’s most-recognized brands.


Our ISO 13485:2016-certified quality system, PCS+, ensures quality development standards are applied to each and every project. From early funding to late stage development, we supercharge our client’s efforts by reducing time to market and providing an exceptional user experience for increased market success. Contact us to make your product vision a reality.


MEDIA CONTACT: Rebecca MacLeod Marketing & PR Consultant (206) 852-7403

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