5 Medical Device Best Practices for Managing Risk to Users, Patients, and the Environment

"It has been almost a year since your mentorship for SDIP Innovations since we were chosen as 2020 Rosenman Innovators. I wanted to say a big fat THANK YOU for your fundamental contribution to SDIP`s progress. Your Insights and expert opinions have been absolutely game-changer for me and SDIP. You…"

"The shared audit program allows us to meet the needs of our supplier auditing procedure without having to schedule individual site audits; this saves us time and resources while enabling us to maintain compliance with the requirements of our quality management system."

"I am working on aging and packaging which they specifically said was assigned based on my experience at Cannon. Your internship program is literally the gift that keeps on giving."

"I just wanted to drop a quick note to thank you all for your support over these past several months. We had a very successful audit this week. Both auditors were very complimentary of the progress we have made since the last audit and that is really a testament to…"

"Look what you have done!  Profusa has a functional QS thanks in large part to you. The GMED auditor has conducted over 700 audits and said we have an extremely good QS and a lot of that credit goes to you… I just wanted to let you know that Profusa…"

"My Manager reviewed and approved this validation, and he called me to say it would be the gold standard for spreadsheet validations for all Nordson Medical D&D sites from this point forward!"

"Our notified body commented that he was impressed with the focus and professionalism of the Emboline team during a recent audit. This is largely a credit to the Cannon Quality Group team. Your team, as always, was extremely organized, well-prepared and professional. Thank you!"

"Everything about the audit process including scheduling, the audit itself, and results & follow-up were seamless and enabled LamaMed Solutions, Inc. to fulfill its requirements for Internal Audit and assessment of QMS conformance with ISO 13485:2016 in advance of our Notified Body audit."

"Our SVP of QA/RA performs mock-FDA audits across all our global facilities. So it was huge compliment for us when, after reviewing all aspects of a software validation authored by Cannon Quality Group, he said it was as good a validation as he had ever seen."

"Cannon Quality Group's staff was highly engaged and responsive to our needs. They were easy to work with and provided a high-quality work product."

"It was by far the best QSR/GMP training – high caliber content and engaging delivery."

"Don’t stress. Call Cannon Quality Group for great project support."

"My 3rd party ISO 13485:2016 audit was extremely beneficial to my company. The auditor was very knowledgeable about the standard and current trends that notified bodies are looking for."

"When strategic partners were doing due diligence, I think they expected to find an empty drawer where the Quality Management System would be. We started showing them the procedures and design files that Cannon Quality Group helped us establish, and they were pleasantly surprised to get just what they wanted…The ability of…"

"Our [CQG] auditor provided findings with value-based explanations and implementation ideas."

"CQG has been with my organization from the nascent stages of our QMS.  Their team of experts coached us on the ISO standards, provided training classes, furnished sample QMS documentation, and were always quick to respond to our endless questions.  Most importantly they were present at our crucial certification and customer audits. …"

"Working with Cannon was a pleasure. They helped us create our first formalized Quality Management System with just the right balance of rigor, detail-orientation, and practicality. I would definitely work with Cannon again in the future on quality management projects."

"JenaValve would like to extend a very appreciated “Thank You” to the whole Cannon Group team in supporting us, JenaValve, through the quality system improvements and associated activities. Your organization has been exceptional in supporting the chaotic schedule and the Cannon Group team members have performed above and beyond the…"

"Your team is great, love the maturity level. Great respect from Quality & Regulatory."

"CQG has really shattered my preconceptions of what contracted support can do for a quality system. They are true professionals from the advice they provide, work they produce, and the integrity of actions. From complicated design control issues, to Process Validation, to Doc Control, they have been a huge resource…"

"Amy has done an amazing job here and we appreciate all her help. Communication with everyone/doc control is good/responsive, and we especially appreciate the quick turnaround on hot DCO’s – they find everything."

"Cannon Quality Group is an absolute pleasure. For our startup, CQG made QSR development and compliance enjoyable and easy. Their unique style and system has allowed us to work at the fast pace required by the market, while still maintaining regulatory compliance."

"Our startup was working with a skeleton quality system and struggling to apply QSR standards, when we brought in the Cannon Quality Group. They overhauled and sharpened our quality system so that it complied with the QSR, in only a few months, which allowed us to have a flawless audit.…"

"When a key employee quit just as the load on my QA group exploded because of a clinical build, CQG stepped in immediately with the resources we needed to keep us going. I hope nothing like this ever happens to us again but, if it does, I’ll know exactly whom…"

"Prior to CQG, our startup worked with another company which made quality slow, very expensive, and highly frustrating. Comparatively, CQG has been a game changer for our company. They have made QSR development and compliance enjoyable and easy, which has allowed us to work at the fast pace required by…"

"Kudos to the Cannon Quality Group for helping us get through our FDA audit with zero 483s and just a few CAPAs.Their expertise in quickly turning our bare bones QMS into a robust system is exactly what was needed."

"Pete is awesome, I appreciate the help he provides to our team and his assistance in various quality needs."

"As a new Quality Director at a young start-up company, I am happy to leave a recommendation for Cannon Quality Group. Cannon Quality Group has an innovative and efficient process in place to bring a working Quality System to a start-up company in a short amount of time. Cannon retains…"