Peggy’s experience in management consulting, venture capital and the medical device industry is a unique fit for Boulder iQ, particularly as the industry moves toward the Medical Device Regulation transition deadline.
BOULDER, Colo. (PRWEB) March 26, 2020
Boulder iQ has named Peggy Fasano chief operating officer.
Fasano will lead operations for the expert contract consulting firm. Boulder iQ provides design engineering, development and turnkey manufacturing for consumer, high-technology and medical products, and regulatory, clinical and quality management system services for the medical device and in-vitro diagnostic industries.
She brings a decade of product development, project management and engineering experience in medical device and biotech industries to Boulder iQ. Before joining the company, Fasano had worked as a senior consultant with Deloitte Consulting in Denver, and as managing director of the Deming Center Venture Fund in Boulder, Colorado. She has held the positions of product development and engineer consultant for Boulder BioMed, and project manager and mechanical engineer for Sophono, Inc., both in Boulder. She also was a mechanical engineer and project manager at Polestar Technologies in Needham, Massachusetts.
Fasano holds a Bachelor of Science in mechanical engineering from Tufts University, and a Master of Business Administration from the University of Colorado.
“Peggy’s experience in management consulting, venture capital and the medical device industry is a unique fit for Boulder iQ, particularly as the industry moves toward the Medical Device Regulation (MDR) transition deadline,” says Jim Kasic, president and CEO.
Manufacturers who sell their devices in the EU face more scrutiny on the clinical evaluation reports (CERs), with new requirements in quality systems, classification rules, technical documentation, unique device identification, post-market surveillance and post-clinical follow-up, he explains. “In this market, Boulder iQ’s ability to provide all design, manufacturing, compliance and regulatory services under one roof is more in demand than ever. Peggy’s ability to guide and manage operations in this complex environment is a huge asset.”
About Boulder iQ (http://www.boulderiq.com)
Boulder iQ is an expert contract consulting firm offering design engineering, development and turnkey manufacturing for consumer, high-technology and medical products, and complete regulatory, clinical and quality management system services for the medical device and in-vitro diagnostic (IVD) industries. Based in Boulder, Colorado, the company is ISO 13485:2016 certified through Boulder BioMed.
The company’s Boulder Medical Device Accelerator provides equity investment in start-up companies seeking product development services, expert mentoring and infrastructure support.