News
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 […]
Read MoreMedical 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 […]
Read MoreDo 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 […]
Read MoreCannon 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. […]
Read MoreFDA 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 […]
Read MoreFDA 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 […]
Read MoreCannon 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 […]
Read MoreAmeda – 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 […]
Read MoreFDA 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 […]
Read MoreNuvoLase, 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 […]
Read MoreRemote 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 […]
Read MoreWhat 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 […]
Read MoreDo 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 […]
Read MoreDo 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 […]
Read MoreCannon 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 […]
Read MoreEvent: “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 […]
Read MoreOffice 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 […]
Read MoreEvent: “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 […]
Read MoreOff 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 […]
Read MoreEvent: 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 […]
Read MoreWatch: 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 […]
Read MoreHow 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 […]
Read MoreWhere 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 […]
Read MoreHow 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 […]
Read MoreDo 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, […]
Read MoreWhy 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 […]
Read MoreReal 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 […]
Read MoreCommon 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 […]
Read MoreWhat’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 […]
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