Choosing the Right Consultant

Operating room with monitor

Published:

RAQA Café

A podcast series that tackles trending Regulatory Affairs and Quality Affairs (RAQA) topics within the MedTech industry.


Finding the right consultant is crucial to the success of your project. In this first episode of NAMSA’s RAQA Café Podcast, our hosts, joined by two guest speakers, delve into the many aspects that must be considered when choosing the best consultant for your product development needs. Providing perspectives from both large-scale manufacturers and small startups, our guest speakers help highlight the different needs that each type of customer requires.

“I think that communication is important with your consultant or CRO. Finding one that you can communicate with, that they understand your needs, that you can have an open conversation, … that is really important.” – Carol Buchert, Senior Manager, NA Regulatory & Quality

Discussion topics include:

  • Determining if the consultant’s technical experience matches your development needs
  • Navigating communication expectations
  • Defining clear responsibilities during project scoping
  • Understanding future support capabilities

 

*Please note that the opinions discussed throughout the podcast are their own and do not reflect that of their current or former employers.

Kelly Kucharczyk, RAC

Kelly Kucharczyk, RAC

Kelly Kucharczyk leads NAMSA’s Global Medical Writing and U.S. Regulatory and Quality Services teams. She has developed numerous regulatory strategies and authored submissions with the goal of efficiently getting safe technologies to market. Prior to joining NAMSA in 2019, Kelly specialized in Orthopedic device strategies and submissions with a long history of working with surgical sutures. She is passionate about helping clients expedite their market access timelines through early and on-going development of regulatory strategy, critical assessment of testing, and communication with regulators.

Richard M. Granquist

Richard M. Granquist

In 2014, Rich joined NAMSA as a Quality Systems Consultant and has now been with the company for eight years. Over his 16 years in the industry, he has participated in numerous AAMI ISO standards committees and currently sits on the committees for ISO 14971, ISO 13485 and ISO 15223. Rich’s medical device industry experience also includes extensive time working with both start-up manufacturers and larger, global device manufacturers. He specializes in quality system development and risk management. Rich started in the medical device industry as a Microbiologist focusing on aseptic technique and terminal sterilization at Cook Medical. During his 8-year career at Cook, he expanded his responsibilities to include coordination of preclinical testing, packaging validation, biocompatibility testing and reprocessing instruction validation for urology and women’s health devices.

Linford Leitch

Linford Leitch

In 2021, Linford joined NAMSA as a Regulatory Consultant. He has 9 years of experience in the medical device industry with direct regulatory experience with Spine, Transcatheter Heart Valves and Hemodialysis devices. He specializes in developing global regulatory strategies for entry to market and maintain strategies throughout product lifecycle.

Carol Buchert

Carol Buchert

Carol Buchert has over 25 years of experience in the medtech industry. She was formerly President, Co-Founder and Co-Owner of a medtech business that successfully sold in 2015. Carol joined NAMSA in 2016, where she managed the U.S.-based regulatory and quality consulting teams, providing regulatory affairs/quality assurance (RAQA) services primarily to North American, European, Japanese and Chinese markets.