News

Top e-Quality Management Systems (eQMS) Software 2020

Are the plethora of electronic Quality Management System (eQMS) software platforms overwhelming? Trying to figure out an option best for your medical device company? Cannon Quality Group can help.

LimFlow – CE Surveillance Audit, A Remote Notified Body Audit

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.”

Cannon Quality Group Announces New Compliance Essentials for Startups Program

FOR IMMEDIATE RELEASE Cannon Quality Group Announces New Compliance Essentials for Startups Program Subscription program helps startups lay the foundation for FDA QSR and ISO 13485 medical device compliance Alamo, CA – September 28, 2020 – Cannon Quality Group (CQG) today announced a new medtech quality management program designed to help startups set the foundation […]

Shared Supplier Audits are saving medtech suppliers multiple days each year!

Suppliers to the medtech industry typically conform to FDA or ISO 13485 quality system standards, and face many customer audit demands, with some suppliers hosting multiple audits per week. Smart suppliers are adopting the Shared Supplier Audit concept to consolidate many customers’ audits into one. Jeff Sauter from Steri-Tek, a sterilizer, describes the simple steps […]

Do you need to move quickly to electronic signature? Code-of Federal Regulations-eCFR-Part 11

Are you ready to move quickly to electronic signature? Cannon Quality Group has helped numerous MedTech clients adopt DocuSign to comply with the electronic Code of Federal Regulations (eCFR) Part 11 by performing necessary validations. Due to the dramatic change in work conditions, we’re making our electronic DocuSign Validation Kit available for only $500 to the MedTech industry to […]

Cannon Quality Group Announces New Shared Supplier Audit at Blue Line Sterilization

Program helps medtech companies complete supplier audit requirements at greatly reduced cost. Alamo, CA – August 13, 2020 – Cannon Quality Group (CQG) today announced a new shared supplier quality audit at Blue Line Sterilization Services (BLSS) in Novato, CA on October 20th, 2020. Cannon Quality Group has pioneered the concept of the Shared Supplier Audit. […]

How to Pivot Your Entire Company to the Cloud on a Tight Timeline

Digitally transforming your value chain during a crisis isn’t easy, but two innovators got it done in the nick of time. To answer this question, Nicolle Cannon of Cannon Quality Group interviewed two innovative manufacturing minds who have recently moved their quality management processes to the cloud themselves: Donielle Baudin, Director of Quality Assurance at […]

Medical Device Business Continuity 2020: Adaptation & Growth During Pandemic

Get your FREE Medical Device Business Continuity 2020 Executive Report. Gain insight and learn the challenges MedTech companies face during the pandemic and how they plan to address them. Cannon Quality Group surveyed executives representing broad product categories including bone implant medical devices, cardiovascular devices, product delivery systems, measuring and monitoring of metabolic attribute devices, […]

Cannon Quality Group Announces New Compliance Essentials for Medtech Startups

Subscription program helps startups lay the foundation for FDA QSR and ISO 13485 medical device compliance Alamo, CA – July 27, 2020 – Cannon Quality Group (CQG) today announced a new medtech quality management program designed to help startups set the foundation for a quality management system compliant to FDA QSR and ISO 13485 requirements. […]

Verily Embraces Remote Auditing

Cannon Quality Group sat down this week with Grace Li, Head of Quality at Verily, to talk about Verily’s recent experience in undergoing a surveillance audit by their notified body. While the on-site audit was originally scheduled for April, the developing COVID-19 pandemic prompted the Verily team to ask their Notified Body if an April […]

Interview with Dreamit Venture’s Adam Dakin: “Sophisticated investors will focus in on the QMS”

Cannon Quality Group recently had the opportunity to sit down to talk shop with Adam Dakin, Managing Director of the Healthtech segment at Philadelphia-based Dreamit Ventures. We were interested in Dreamit-backed companies (some of which are also CQG clients), Dreamit’s approach to investing in and building healthtech companies, and the role of quality management is […]

Case Study: North Coast Medical

North Coast Medical, Morgan Hill, CA, is a global occupational, physical and hand rehabilitation distributor specializing in supplying the most commonly requested brands in the market. Hundreds of the company’s products are also considered medical devices. The distributor came under FDA scrutiny and was receiving recurring FDA 483s. Learn how Cannon Quality Group helped the […]

Medical Device Companies Business Continuity Survey 2020

2020 has become a year to find new ways to ensure business continuity. How are medical device companies of all sizes innovating via remote auditing, facilitating work-from-home or safe distancing in controlled environment workspaces, and more? We’re conducting research among our clients and colleagues and value your insights and expertise. Let’s hear from you: https://forms.gle/dobAffivdgwx2FfNA […]

Do you need medical device compliance guidance for FDA Covid-19 Emergency Use Authorization (EUA) products?

Are you a little confused or uncertain on the course of action to ensure medical device quality assurance for FDA Covid-19 Emergency Use Authorization (EUA)? Need some guidance for Covid-19 EUA? You’re not alone. Cannon Quality Group is pleased to announce a new series of infographics to help simplify the process and increase the medical […]

Cannon Quality Group Supports Mental Health Month in May

May is Mental Health Month and this year it’s more important than ever to take stock of our mental health regularly. To that end, Cannon Quality Group has provided each employee two half days off this month, away from the fast pace of the medtech industry, specifically to devote to his/her mental health and wellbeing. […]

FDA Covid-19 Emergency Use Authorization (EUA): Non-Invasive Remote Monitoring Devices

Many of our clients and colleagues in the medical device community, driven to help patients and the medical provider community in this challenging time, want to pursue FDA’s Covid-19 Emergency Use Authorization (EUA) to do so. If you’re a medical device manufacturer or supplier and have taken a look at FDA guidance for Covid-19 EUA […]

FDA Covid-19 Emergency Use Authorization (EUA): Face Masks & Respirators

Many of our clients and colleagues in the medical device community, driven to help patients and the medical provider community in this challenging time, want to pursue FDA’s Covid-19 Emergency Use Authorization (EUA) to do so. If you’re a medical device manufacturer or supplier and have taken a look at FDA guidance for Covid-19 EUA […]

Cannon Quality Group Streamlines Quality Management System for Theravent Snoring Aid

Theravent markets an anti-snoring device sold via home health distributors, CVS, Walgreens, and Amazon. It approached Cannon Quality Group when the medical device company was starting. The CEO was taking the technology of a higher classification medical device to support sleep apnea and retooling to target snoring. He required rapid response firepower in quality assurance […]

Ameda – Medical Device Remote Notified Body Audit

Ameda Inc. has been a leader in breast milk for babies for over 75 years. The company has 59 employees and uses a team from Cannon Quality Group (Alamo, CA) to initiate and manage their quality processes. Ameda recently underwent a Medical Device Single Audit Program (MDSAP) Surveillance Audit including ISO 13485:2016, FDA 21 CFR […]

FDA Emergency Use Authorization (EUA); Medical Ventilators

Many of our clients and colleagues in the medical device community, driven to help patients and the medical provider community in this challenging time, want to pursue FDA’s Emergency Use Authorization (EUA) to do so. If you’re a medical device manufacturer or supplier and have taken a look at FDA guidance for EUA and are […]

NuvoLase, Inc. – Medical Device Remote Notified Body Audit

Recently Cannon Quality Group helped one of our clients navigate a remote notified body audit in order to help them keep on track despite global pandemic challenges. NuvoLase did not have an electronic Quality Management System (eQMS) in place at the time. The PinPointe FootLaser was the first light-based device to receive FDA clearance specific […]

Remote Auditing – Your Tips on a Successful Virtual Notified Body Audit

MedTech companies large and small face new challenges in keeping operations moving during the pandemic. Most audits, for example, were traditionally conducted on-site but now the industry is finding new ways to conduct audits remotely while maintaining high standards. Avinger, Inc. is a commercial-stage medical device company in Redwood City that designs, manufactures and sells […]

What is required for EU MDR compliance? Will enforcement be delayed?

The EU MDR originally scheduled to come into force on May 26, 2020 may be delayed for 6 months to a year. EU MDR replaces the EU’s current Medical Device Directive (93/42/EEC) and Directive on Active Implantable Medical Devices (90/385/EEC). All manufacturers of medical devices for sale within the EU must adhere to strict guidelines […]

Do you need to audit Sterigenics Hayward in 2020?

Cannon Quality Group has pioneered the concept of the Shared Supplier Audit. CQG founder Nicolle Cannon had the idea some years back when she noticed that so many of her client companies were auditing the same suppliers. Especially for start-ups and emerging medical device companies, sending scarce resources out to a supplier for an audit […]

Do you need to move quickly to electronic signature? Code-of Federal Regulations-eCFR-Part II

Many of our MedTech start-up and pre-commercial clients use a paper based quality management system and when a small team is generally in the same place, it can work for sign-offs if limited in scope and managed well for QMS at medical device companies. However, you may find yourself in a position where you need […]

Cannon Quality Group announces 2 new shared supplier audits for Steri-Tek and Nelson Labs!

Cannon Quality Group has pioneered the concept of the Shared Supplier Audit. CQG founder Nicolle Cannon had the idea some years back when she noticed that so many of her client companies were auditing the same suppliers. Especially for start-ups and emerging medical device companies, sending scarce resources out to a supplier for an audit […]

Event: “Best practices for medtech suppliers supporting new product introductions (NPI) in 2020” set for Wednesday, January 29th

Cannon Quality Group’s Founders Club is excited to announce the next topic in our ongoing event series in Redwood City, “Best practices for medtech suppliers supporting new product introductions (NPI) in 2020”. How can suppliers best support our startup clients, who need low volume parts with demanding specifications, all in a short turnaround? We’ll again […]

Office Hours at UCSF Rosenman Institute

Nicolle Cannon, Cannon Quality Group Are you unsure about when to introduce a quality management system for your early-stage venture? Perhaps the step seems daunting and you’re putting it off? Apply to meet with Nicolle Cannon of the Cannon Quality Group for a 45-minute slot the afternoon of Thursday, November 21. CQG specializes in developing […]

Event: “eQMS Solutions for Startup and Early Stage Medtech Companies” set for Thurs Oct 3

Cannon Quality Group is a full service quality management department outsourceable on a fractional basis to startup and emerging medtech companies. We field a lot of questions from clients on the selection and use of electronic Quality Management Systems. With that in mind, CQG is preparing an event for our clients on October 3rd with […]

Off to College: Cannon Quality Group Supporting Future Entrepreneurs

On May 20, a small group of California Polytechnic State University alumni and supporters from the medtech industry will gather in San Luis Obispo to meet with select students, faculty, and Center for Innovation and Entrepreneurship (CIE) staff for a 1-day planning summit. Among them will be Nicolle Cannon, founder/CEO of the Cannon Quality Group […]

Event: Cannon Quality Group’s Industry Mixer on MDR Set for Weds Apr 24th

The medical device industry is again busy dealing with changes to applicable standards and regulations, this time the transition from the EU’s Medical Device Directive (MDD) to the more sweeping Medical Device Regulation (MDR). As usual, there are deadlines and time pressure. Is the transition just an added burden or an opportunity to restructure processes […]

Watch: When Is It Time for a Quality Management System for Your Early Stage Firm?

Starting up a medical device company takes a lot of time, money and effort. In addition to the research, fundraising, product development, clinical trials, etc., the FDA and other regulatory agencies require a quality system to be defined and maintained. But when is the best time to implement a quality system in your medical device […]

How Much Quality Can a Startup Stand?

Are you unsure about when to introduce a quality management system for your early-stage medical device venture? Perhaps the step seems daunting and you’re putting it off? Nicolle Cannon, founder of Cannon Quality Group, will be addressing this topic in an upcoming webinar on March 7. (More information here: https://bit.ly/2Wraz1y) Some see it as the […]

Where does Product Lifecycle Management fit in your IT infrastructure?

Many of Cannon Quality Group’s clients in the medical device field are in the process of evaluating Product Lifecycle Management (PLM) platforms for their organizations, typically including an eQMS solution to allow them to go paperless in their quality management activities. I sat down recently with Cheryl Simmons, an account executive from Propel, a leader […]

How Supplier-Friendly Shared Audits are Creating a Win-Win for the Medical Device Industry

With popular ride-sharing apps, you can often save money going from A to B by joining up with other passengers who are going in the same direction. If various parties are going to the same place, can they save money by riding together? With supplier audits, the answer is “yes”. Especially for start-ups and emerging […]

Do you have your year-end quality management checklist ready?

Before we get to all the challenges that await us as quality professionals in 2019, now’s the time to take a cold hard look at the to-do list for the remainder of 2018. Why? Well, if you stack up the people on your staff using up their vacation allowance, the relatively dead week around Thanksgiving, […]

Why Versatility is a Core Value at Cannon Quality Group

By Richard Goeb – CQG Sales Note: This is the first in a series of employee-penned blog posts focused on Cannon Quality Group’s Core Values, known as “VITAL.” As a veteran of the medical device industry and having worked at numerous organizations throughout my career, I have seen many attempts at instituting some defined set of […]

Real World Challenges when Transitioning to ISO 13485:2016

At a recent medical device industry event in San Francisco, speaker Vee Arya from Cannon Quality Group asked the audience for a show of hands regarding their transition status to the 2016 version of the ISO 13485 standard for Quality Management Systems, which must be completed by March 31, 2019. Less than half the audience […]

Common Quality System Challenges: Document Change Control

One of the challenges for medical device companies, especially startups, is reviewing, approving, and implementing changes effectively as part of the Quality Management System.  Startup companies have varying degrees of knowledge and experience with Quality Management Systems.  The following are some of the common hurdles to overcome when meeting Document Change Control requirements whether it […]

What’s New at CQG – Q2 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 […]