What’s New at CQG – Q2 2018

Posted on: May 18, 2018

Happy Spring! We’ve got some important updates for you regarding ISO 13485:2016, Shared Supplier Audits, our CQG Team as well as community involvement. Enjoy the latest!

Are You Ready for ISO 13485:2016??

The Team at Cannon Quality Group has been busy helping our clients transition their Quality Systems to meet the ISO 13485:2016 standard by March 2019, as required. A big part of this change is assessing and identifying Risk throughout the QMS. With the new standard, there’s greater emphasis on quality management systems throughout the supply chain and product life cycle, as well as device usability and post-market surveillance.

If you haven’t yet started to execute your plans for transitioning your QMS, or need help with a post implementation audit, we can assist!

Call or email us today – We’re here to help you along the way! Here’s a link to make it easy!

Ongoing Team Training

At CQG, we take our client role as “quality professional” very seriously. By staying current with changes in the medical device industry, quality protocols and regulations, we ensure our Team is well versed and empowered to provide sound and reliable guidance where needed. If we don’t have the answers, we will do what it takes to find solutions.

Upcoming Community Service

CQG’s Team is passionate about giving back (which is part of why we do what we do!) In addition, we like to help our community in any way we can. Some of our Team will be at MedShare’s volunteer and distribution center in San Leandro on June 15, 2018 from 9am-12 noon to lend a hand. We would LOVE for you to join us! Please email us here by June 1 to sign up – or for more information.

MedShare is a 501c(3) humanitarian aid organization dedicated to improving the quality of life of people, communities and the planet by sourcing and directly delivering surplus medical supplies and equipment to communities in need around the world.

Shared Supplier Audits Gaining Steam

Upcoming Shared Supplier Audits

Cannon Quality Group has pioneered the idea of shared supplier audits in the medical device community. In a shared supplier audit, a group of clients bands together to perform one audit in place of many. It’s the “Uber Pool” of audits! Each participant is consulted beforehand to make sure all agenda items are noted and covered. Each participant gets a customized report at the end. Suppliers like it because it reduces their audit support burden, and clients like it because it saves them time and money. Below is the current list of upcoming shared audits in 2018. Let us know if you’d like to jump on board one of these. If you don’t see a supplier of yours on the list, let us know!
If you would like to take part in any of our scheduled Shared Supplier Audits, please email our Audits group: audits@cannonqg.com TODAY, or call 925-944-9468.

For more on CQG’s auditing services and scheduling information, click here.

Core Values

At CQG, we hold every employee accountable to be the change in quality, to pursue integrity and versatility, work with the team, and maintain a healthy balance in their lives.

Testimonials

"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!"

-Kim Trottier/Quality Information Systems Manager, Nordson Medical

"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!"

-Scott Russell/President and CEO at Emboline, Inc.

"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."

-Lloyd Griese/Quality and Regulatory Consultant, LamaMed Solutions, Inc.

"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."

-Ron Koronkowski/Director of Quality & Regulatory, Vention Medical, Inc.

"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."

-Caroline Jewett/Consultant for PvP Biotech

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

-Robert Angelopoulos/Sr. Engineering Manager, Powervision, Inc.

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

-David Freed/Sr. Quality Director, AcelRx Pharmaceuticals, Inc.

"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."

-Tom Mason/Director QA, Vactronix Scientific

"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…"

-Don Bogue/President/CEO, Compact Imaging

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

-Kyle Dion/Quality Specialist, BlueLine Sterilization Services

"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. …"

-Kathleen Perry/Twist Biosciences

"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."

-Gideon Wald/CTO Welkin Health

"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…"

-Peter Wulff/CFO JenaValve

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

-Mark Adler/Senior Director of R&D JenaValve

"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…"

-David Hesting/QA Director, Profusa, Inc.

"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."

-Bijesh Chandran/VP of Quality, R2 Dermatology

"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."

-Andrew Hosford/Director of Engineering, Gauss Surgical

"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.…"

-CQG client/

"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…"

-Ari Zak/Sr. VP, Clinical, Regulatory & Quality and Corporate Counsel, PowerVision

"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…"

-CQG Client/

"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."

-Shaun R. Bagai/CEO – RenovoRx, Inc.

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

-Kityee Au-Yeung/Profusa

"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…"

-Delane Dale/Quality Director – BioInspire Technologies
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