Watch RQM+ Live! on demand

On Thursday, 13 October, RQM+ subject matter experts hosted episode #61 of our Live! show. Fill out the form to get access to the on-demand recording now.

Each year RQM+ supports hundreds of FDA 510(k)'s and EU technical documentation files for either medical devices containing software or stand-alone software devices. In this show our regulatory experts will discuss both FDA and EU deficiencies and additional information requests associated with software (real case studies), as well as best practices and solutions to avoid these pain points in your submissions.

Devices and challenges discussed will include: 

• Artificial Intelligence (AI) machine learning and acceptability of change control plans 
• Defining proprietary algorithms and controlling changes in those algorithms 
• Cybersecurity implementation and alignment with ISO 14971 (Risk management) 
• Lack of information on connected devices 
• Aligning terminology and documentation across various requirements and processes (AGILE, ISO 62304, QSR, MDR, IVDR) 
• Off-the-shelf software and expectations for verification and validation testing. 

Please sign up to access the recording by filling out the form. 

Meet the RQM+ PANELISTS:

Allison Komiyama, Ph.D., RAC
President, AcKRS

Allison is a regulatory consultant focused on FDA submissions for the medical device industry. Throughout her career, she has been actively involved in hundreds of pre-submissions and premarket submissions for a wide array of medical device companies. Her previous company (AcKnowledge Regulatory Strategies, LLC) that she founded in 2014 was purchased by RQM+ in late 2021. At RQM+, she and her team continue to work with small to large medical device companies as they now support all device types during the entire product life cycle.

Kevin Go, MBA, RAC, CQA
Senior Principal, Regulatory and Quality Practice

Kevin is Senior Principal, Regulatory and Quality Practice at RQM+ and helps clients navigate US and EU regulations. Prior to RQM+, he worked at the FDA for over five and a half years serving as a Lead Reviewer in the Division of Orthopedic Devices where he reviewed numerous pre- and post-market submissions. Additionally, Kevin served as an Advisor to the CDRH Innovation group and Payor Communication Task Force, where he provided early regulatory and reimbursement assistance to small businesses.

Hrishkesh Gadagkar
Principal Engineer

As a Principal Engineer, Rishi helps to provide clients with industry-leading regulatory and quality consulting services throughout the entire product lifecycle. Rishi has worked at several large, mid-size and smaller start-ups where he was leading engineering and Manufacturing functions. He has launched several medical devices that were software controlled and some incorporated machine learning algorithms. Rishi brings deep understanding of requirements for implementing high-quality software systems that are reliable and secure.