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LimFlow – CE Surveillance Audit, A Remote Notified Body Audit
September 29, 2020

LimFlow has internal regulatory and quality employees and additionally leverages a team from Cannon Quality Group to maintain their quality processes. LimfFow recently underwent a CE Surveillance Audit with their notified body DEKRA.

Due to current travel restrictions, this comprehensive audit was performed remotely. LimFlow was supported before and during the remote audit by the team from Cannon Quality Group. CQG interviewed LimFlow’s VP of Quality and Regulatory, Zachary Woodson, post-audit to get feedback on team performance, managing the remote connections, and meeting auditors’ expectations. Cannon Quality Group team members were Founder/CEO, Nicolle Cannon, Jr. Quality Engineer, Michelle Reyes and Quality Engineer, Jeff Nguyen.

We asked Zachary what some of the biggest challenges were for this remote audit, “The audit was challenging since it went from midnight to 8 am,” says Zachary Woodson, VP of Quality and Regulatory at the company. ”The CQG team was there for the entire time addressing questions, finding documents, creating reports, and pushing back on potential findings.”

LimFlow was founded in 2012 with the deep belief that more could be done for the millions of patients worldwide suffering from the most severe form of peripheral artery disease — Chronic Limb-Threatening Ischemia (CLTI) — and who are facing the prospect of amputation.

LimFlow has internal regulatory and quality employees and additionally leverages a team from Cannon Quality Group (Alamo, CA) to maintain their quality processes. LimfFow recently underwent a CE Surveillance Audit with their notified body DEKRA.

Due to current travel restrictions, this comprehensive audit was performed remotely. LimFlow was supported before and during the remote audit by the team from Cannon Quality Group. CQG interviewed LimFlow’s VP of Quality and Regulatory, Zachary Woodson, post-audit to get feedback on team performance, managing the remote connections, and meeting auditors’ expectations. Cannon Quality Group team members were Founder/CEO, Nicolle Cannon, Jr. Quality Engineer, Michelle Reyes and Quality Engineer, Jeff Nguyen.

We asked Zachary what some of the biggest challenges were for this remote audit, “The audit was challenging since it went from midnight to 8 am,” says Zachary Woodson, VP of Quality and Regulatory at the company. ”The CQG team was there for the entire time addressing questions, finding documents, creating reports, and pushing back on potential findings.”

Dealing with a pair of auditors over an extended period of time remotely involves both hard skills on the technical side as well as soft skills that recognize and deal with the challenges of not being in the same room. This audit had the additional challenges of being on Paris time while LimFlow and CQG’s support teams were on Pacific Standard time. That being said, “CQG was there every step of the way and their support was critical. Nicolle and her team were professional and super responsive. The remote audit was a success thanks to their help.”

Zachary’s tips and tricks to ensure remote audit success:

  • Giving the auditors access to documents electronically can speed up the process, though that also comes with risks since it makes it easier for them to search and find.
  • Utilize some form of IM service (e.g., Slack, WhatsApp, MT, etc.) to facilitate group conversations.

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