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

September 23, 2022

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

The certification follows Boston Engineering’s annual assessment of its QMS by the British Standards Institute (BSI). Recertification to the ISO 9001 and ISO 13485 standards demonstrates Boston Engineering’s continued commitment to the highest level of quality controls related to customer focus, management, internal processes, and external relationships.

“We are proud of our company-wide commitment to quality, compliance, and communication that is reflected in our ISO 9001:2015 and ISO 13485:2016 certifications,” said Bob Treiber, president and co-founder of Boston Engineering. “Our disciplined product development process provides a defined roadmap as we work in uncharted territory to transform groundbreaking ideas into successful products and technologies.”

ISO 9001 establishes comprehensive QMS requirements for one or more stages of the product design and development consulting 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 from concept development through commercialization. The company specializes in solving complex challenges in defense and security, medical devices, and commercial industries. Founded in 1995, Boston Engineering is certified to ISO 9001:2015 and ISO 13485:2016 standards. Boston Engineering is an Ansys Certified Channel Partner and PTC Platinum Partner. The company is headquartered in Waltham, Mass., and is online at www.boston-engineering.com.

Contact

Rachel Cashman
781-314-0741
rlamy@boston-engineering.com