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RECORDED ON April 20, 2023 | 1:00 p.m. - 2:00 p.m. EDT

Regulatory Strategy as Competitive Advantage

How companies that think differently about regulatory affairs
can turn it into a revenue-generating differentiator

For most MedTech companies, regulatory affairs is a process. It’s a series of prescribed steps and activities required to market and sell products in different countries or regions. For most MedTech companies this means that regulatory affairs is treated as an operational cost center – something to constrain and wring cost-savings from. This focus prevents companies from realizing the potential of a bigger-picture regulatory strategy, and creates friction between regulatory and go-to-market teams.

Companies that invest in improving regulatory performance can bring new products to market more quickly than their competitors. They can move swiftly to capture market share when new regulations are implemented or competitors stumble. And they can still realize operational cost savings through more efficient execution.


  • Regulatory Affairs Professional in the MedTech Industry


Bruce McKean

Bruce McKean
Director of Regulatory
Rimsys Regulatory Management Software

Bruce McKean is the director of regulatory at Rimsys Regulatory Management Software. He has more than 25 years of medical device industry experience as a regulatory professional specializing in quality and regulatory (Q&R) compliance, design controls, and Q&R-related mergers and acquisitions. During his career, McKean has focused on implementing and maintaining design controls, product submissions, quality management systems internal to his company and for newly acquired companies, corporate Q&R internal audit programs, and performing Q&R due diligence audits on target companies. Prior to joining Rimsys, he served as director of Q&R operations at Philips Healthcare, where he led a corporate-wide Medical Device Single Audit Program (MDSAP) compliance initiative and was focused on the implementation of the EU Medical Device Regulation (EU MDR). 

James Gianoustos

James Gianoutsos
Founder & CEO
Rimsys Regulatory Management Software

James Gianoutsos is the Founder & CEO of Rimsys Regulatory Management Software, a cloud-based solution to digitize, automate, and create regulatory order for MedTech companies. James is a quality assurance and regulatory affairs professional who has a diverse background in the medical device, pharmaceutical and biologics industries. James’ professional experience includes the design, premarket approval, clinical trials, manufacturing, distribution and post-market surveillance of drug products and class I, II, and III devices. It also includes products in a variety of clinical applications including infant jaundice management, neonatal respiratory care, infant incubation, sleep therapy, management of respiratory insufficiency, surgical adhesive for internal use, surgical sealant for prevention of gastrointestinal leaks, and bone healing accelerants. James has extensive experience in establishing and maintaining quality management systems in accordance with FDA, ISO, cGMP, MDD, MDR, MDSAP, CMDCAS requirements and standards and has helped develop and submit multiple regulatory filings including Premarket Approvals (PMA), 510(k)s, Design Dossiers, Technical Files and INDs.  James holds a Bachelor of Science in operations management as well as a Master of Business Administration (MBA) with a concentration in operations management and strategy from the University of Pittsburgh – Katz Graduate School of Business. 

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