Choosing the Right Consultant

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.

Meet the Speakers

Carol Buchert; Senior Manager, N.A. Regulatory & Quality Consulting, NAMSA

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 continues to manage 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.

Kelly Kucharczyk, RAC; Associate Director, Global Medical Writing and NA Regulatory & Quality Services, NAMSA

Kelly Kucharczyk 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.

Linford Leitch; Former Regulatory Consultant, NAMSA

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.

Richard Granquist; Senior Quality System Consultant, NAMSA

Rich Granquist has 17 years of experience in the medical device industry and has spent 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 preclinical testing including, packaging validation, biocompatibility testing and reprocessing instruction validation for urology and women’s health devices. He spent several years as a Quality Engineer performing complaint investigations, root cause investigation and product development focusing on aortic intervention vascular devices. In 2014, Rich joined NAMSA as a Quality Systems Consultant. Over his 16 years in the medical device industry, he has participated in numerous AAMI ISO standards committees and currently sits on the AAMI working groups for AAMI ISO 14971, AAMI ISO/TR24971, AAMI ISO 13485 and AAMI ISO 15223.