Attend our upcoming RQM+ Live! show

13 Oct. 2022  |  11 a.m. ET / 5 p.m. CET

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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. 

Bring your toughest software submission questions for our team of experts including former FDA CDRH 510(k) reviewers and NB leaders! 

 

Meet the RQM+ PANELISTS:

Nancy Morrison Square

Nancy Morrison, RAC
Vice President, Intelligence & Innovation

Nancy has more than 30 years of quality and regulatory experience in the medical industry with U.S. and global regulatory submission experience. She has spent the last nine years with RQM+, providing EU MDR and IVDR leadership in developing solutions and implementing the regulations at startup, mid-size and multinational medical device and combination product companies. 


allison_komiyama_headshot_squareAllison Komiyama, Ph.D., RAC
President, AcKRS\ntelligence & Innovation - IVD

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_Headshot_Square-minKevin Go, RAC
Project Engineer

Kevin is a Project Engineer at RQM+, where he helps client 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.

Fill out the form to register for the Live! show.