Thursday August 30, 2018 0 comments
BOULDER -- Boulder iQ announced it has named Carrie Hetrick VP of regulatory and clinical affairs.
Hetrick will lead the consulting firm’s regulatory work for the medical device and in-vitro diagnostic (IVD) industries, within the U.S. and internationally.
The company said Hetrick brings more than 18 years of expertise in quality management systems and business process improvement/management, complex regulatory submissions, and quality and regulatory compliance consulting to Boulder iQ.
Hetrick’s experience includes U.S. Food and Drug Administration pre-market notifications, pre-market amendments, OUS regulatory submissions, clinical evaluation reports, clinical studies, regulatory audits and implementation of quality systems.
Hetrick has helped hundreds of companies navigate the 510(k) and CE Mark clearance and approval processes, Boulder iQ said.
Before joining Boulder iQ, Hetrick held executive-level regulatory positions at publicly held medical device companies as well as small startup manufacturers.
She has a wide range of experience with multiple medtech industries, clients, and products from her position as a senior consultant/trainer for Oriel STAT A MATRIX and as a senior global regulatory consultant at Emergo Global Consulting, LLC.
Hetrick holds a Doctor of Dental Surgery degree from the University of Colorado Health Science Center,and Bachelor of Science degree from Pacific Lutheran University.
She currently is pursuing a Master of Science degree in Advanced Biotechnology, concentrating in regulatory science, from Johns Hopkins University.
Boulder iQ specializes in assisting medical device companies with clearances and approvals for both the U.S. and European markets.
“Regulatory agencies are focusing more and more on risk and hazard analysis,” said Hetrick. “Boulder iQ aids companies in navigating the legal and regulatory requirements and standards needed to obtain marketing application approvals and post-market activities.”
Jim Kasic, president and CEO of Boulder iQ, said the process of getting medical devices through the FDA’s 510(k) process and obtaining the CE Mark is more straightforward now than in the past.
“However, the new Medical Device Regulation (MDR) 2017/745 in Europe has imposed significantly more scrutiny on the clinical evaluation reports,” he said.
“In fact, to meet the May 26, 2020 transition deadline, manufacturers who sell their devices in the EU will be required to meet the MDR and the new quality system requirements, classification rules, technical documentation, Unique Device Identification (UDI), Postmarket Surveillance (PMS), and Post Clinical Follow-Up (PCFU).
“This ultimately will create a huge bottleneck in the industry.”