Boston Engineering Announces ISO 9001:2015 and ISO 13485:2016 Certifications

Sep 24, 2018

ISO 9001 and ISO 13485 Certified - Boston Engineering

Waltham, Mass. – Product development firm Boston Engineering today announced certification to the latest ISO 9001 and ISO 13485 standards. The news underscores Boston Engineering’s quality management system (QMS) best practices for product design and development across commercial, defense, and medical industries.

Boston Engineering received ISO 9001:2015 and ISO 13485:2016 certifications following the annual assessment of its QMS by the British Standards Institute (BSI). Recertification to the ISO 9001 and ISO 13485 standards demonstrates Boston Engineering’s continuing commitment to the highest level of quality controls related to customer focus, management, internal processes, and external relationships.

“Our disciplined product development process provides a defined roadmap as we work in uncharted territory to transform groundbreaking ideas into successful products and technologies,” said Bob Treiber, president and co-founder of Boston Engineering. “Certification for ISO 9001:2015 and ISO 13485:2016 reflects a company-wide commitment to quality, compliance, and communication during each phase of the product development lifecycle.”

ISO 9001 establishes comprehensive QMS requirements for one or more stages of the product development lifecycle for consumer, commercial, industrial, and defense markets. ISO 9001 also addresses implementation support services for product lifecycle management systems. ISO 13485 is based on the ISO 9001 format with additional requirements to ensure the consistent design, development, production, installation, and delivery of medical devices that are safe and effective for their intended purpose.

Boston Engineering’s ISO 9001:2015 and ISO 13485:2016 certificates of registration are available online.

About Boston Engineering

Boston Engineering provides product design and engineering consulting across the entire product development process – from concept through connected product capabilities. Certified to ISO 9001:2015 and ISO 13485:2016 standards, the company’s industry expertise includes defense & security, medical devices, robotics, and commercial products. Boston Engineering is also an Internet of Things (IoT) ThingWorx Partner and a PTC Platinum Partner. Founded in 1995, Boston Engineering is headquartered in Waltham, Mass. Learn more at


Alex Wallace
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