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Compliance Essentials for Startups Program
Device Compliance Essentials for Startups combines a comprehensive set of templates for early Standard Operating Procedures (SOPs) with live coaching sessions. The templates cover fundamental areas important to startups like document control, design control and supplier quality to ensure optimal supplier audits, and are available immediately here: www.cannonqualitygroup.com/services/essentials/. The budget-friendly program consists of 9 fundamental […]
Read MoreGood Documentation Practices
Everyone in the organization generates, receives and handles documents related to your business. Naturally, the document control staff needs to be very well trained in procedures governing generation, transmission, and approval of documents, but since all employees handle documents, everyone should have a solid understanding of the basics. It goes without saying that documents should […]
Read MoreCannon Quality Group CEO and Founder, Nicolle Cannon, to Continue Role as Strategic Adviser to UCSF Rosenman Institute for Medtech Startups
Cannon Quality Group Continues to Serve the Institute as an Enterprise Partner
Cannon Quality Group (CQG), a leading provider of compliant Quality Management solutions to the medical device, Medtech, life sciences, biotech, and IVD industries, has announced that its CEO and founder Nicolle Cannon will continue her role as a strategic adviser to UCSF Rosenman Institute Medtech entrepreneurs and that Cannon Quality Group will continue to serve the institute as an enterprise partner.
Remote Auditing FAQs Cannon Quality Group
The pandemic has increased the need for remote audits in medical device, Medtech, Pharma, IVDR, and other companies in the life science industries. Over the last 14 months, Cannon Quality Group has helped migrate companies to a remote audit process for notified body audits, supplier audits, internal audits, and more.
Read MoreNavigating eQMS with Enzyme
The use of electronic Quality Management Systems (eQMS) is becoming standard technology in Medtech startups. They offer the promise of automation, improving compliance, reducing cost, increasing productivity, enhancing traceability, and reducing documentation burden. As a full-service outsourced quality management company, we get asked quite frequently what is the best eQMS platform on the market and […]
Read MoreNavigating eQMS Today with Enzyme
The use of electronic Quality Management Systems (eQMS) are becoming standard technology in Medtech startups. They offer the promise of automation, improving compliance, reducing cost, increasing productivity, enhancing traceability, and reducing documentation burden. In this first webinar of our new quarterly series, Cannon Quality Group CEO and founder, Nicolle Cannon and Enzyme CEO and co-founder […]
Read MoreCannon Quality Group Q&A: Remote Audits March 2021 – Part B
What is the best way to coordinate the audit team if all members work from a home office? Both during coordination of an audit team and during the audit itself. A clear agenda including time slots, a dry run, and understanding and creating breakout rooms is critical. Also, include who will be in them and […]
Read MoreMedtech Suppliers Offering Shared Audits to Save Time and Reduce Exposure
by Nicolle Cannon Most manufacturers of medical devices depend on numerous suppliers to provide components, assemblies, design services, sterilization and more. Manufacturers are required to audit key suppliers periodically to ensure compliance with their quality agreements. For some suppliers, this could mean hosting over a hundred audits per year, which represents a significant cost in […]
Read MoreCannon Quality Group Q&A: Remote Audits March 2021
How will Notified Bodies view companies that have not done their internal audits (on site or remote) but have put a documented COVID-19 mitigation in place for 2020? Will they issue an NC for this? A documented mitigation is great, but if the organization was active regardless of COVID, the areas that were active should […]
Read MoreNicolle Cannon to Host Quarterly Webinar Series on Electronic Quality Management Systems
Interactive Series to Look at Leading Vendors and Highlight Key Factors for Successful Implementation Cannon Quality Group (CQG), a leading provider of compliant Quality Management solutions to the medical device, Medtech, life sciences, biotech, and IVD industries, has announced that its CEO and founder Nicolle Cannon will be hosting a quarterly interactive webinar series on […]
Read MoreMastering Remote Audits in 2021 and Beyond – Virtual Lunch and Learn With Cannon Quality Group
Join Us for an Invite-Only Virtual Event: Mastering Remote Audits in 2021 and Beyond Virtual Lunch and Learn With Cannon Quality Group February 25, 2021 | 12:00p.m.-1:00 p.m. MST Audits have always been a crucial component of the Medtech industry but current events have forced an increasing number of audits to be conducted remotely. Join […]
Read MoreCannon Quality Group Q&A: Remote Audits February 2021
Is there a need to revisit the audit contract to add some “requirements of remote auditing” language? This depends on how detailed your contract is and your relationship with the supplier. If you have a contract with the supplier, they will need everything detailed in a contract to execute it. That being said, it never […]
Read MoreRevised Quality Management Survey
Could your company be spending too much on Quality Management in 2021? The following brief 1-minute survey is intended to gather data on medical device company spend on Quality Management. Respondents will receive survey results and analysis within 2 weeks of closing out the survey. Share Your Insights: https://forms.gle/teubDBd5JvTPXBfs6
Read MoreGreenlight Guru 2020 Summit: Audits. Let’s get back to Auditing, REMOTELY!
Cannon Quality Group CEO Nicolle Cannon shares experiences as an early adopter of remote auditing. The presentation covers both the hard skills of getting comfortable with various eQMS technology platforms as well as the soft skills of effective communication between auditor and “auditee.” Watch the webinar:
Read MoreuLab Systems & Quality Management System (QMS) Processes
uLab Systems is advancing the orthodontic industry with digital treatment planning software and aligner products that let orthodontists take back control of their treatment plans. The company recently went through an initial ISO 13485/MDSAP certification audit. Cannon Quality Group set up and manages uLabs’ QMS processes including Document Control, Training, Complaint Management and Quality Engineering […]
Read MoreQuality Management Survey
Could your company be spending too much on Quality Management in 2021? The following brief 1-minute survey is intended to gather data on company spend on Quality Management. Respondents will receive survey results and analysis within 2 weeks of closing out the survey. All responses are confidential and individual respondents or their companies will not […]
Read MoreMassMEDIC 1/13 Event
Cannon Quality Group CEO and founder Nicolle Cannon will be presenting at an upcoming MasterClass IGNITE invite-only event for startups sponsored by the Massachusetts Medical Device Industry Council (MassMEDIC) on January 13, 2021.
Read MoreVideo with Nicolle Cannon
Medtech Manufacturers have been given an additional year to prepare for new European Union regulations, but pivots in business and an altered timeline for Medical Device Regulation may drive the need to comply sooner. How do you refocus and start working towards the transition in the midst of a pandemic? Nicolle Cannon, founder/CEO of Cannon […]
Read More3 Quality Management Trends in 2021
We recently sat down with Cannon Quality Group founder/CEO Nicolle Cannon on behalf of MasterControl to get her thoughts on the most important trends in medtech quality management heading into 2021. She identifies movement towards eQMS adoption, remote auditing, and shared supplier audits as 2021 trends to watch. Read the full article here: https://www.mastercontrol.com/gxp-lifeline/3-quality-management-trends-in-2021/
Read MoreNicolle Cannon Joins Cal Poly’s Biomed Industrial Advisory Board
Role to help guide the way BMED program addresses innovation and compliance DECEMBER 15, 2020 Cannon Quality Group (CQG), a leading provider of compliant Quality Management solutions to the medical device, Medtech, life sciences, biotech, and IVD industries, has announced that its CEO and founder Nicolle Cannon has been named to the Biomed Industrial Advisory […]
Read MoreAre you spending too much on quality management?
As supply chain issues and the reality of remote workers and auditing have impacted MedTech companies, Cannon Quality Group is committed to helping MedTech companies of all sizes navigate the new terrain of quality management. I encourage you to share your insights to help other executives in our field plan for 2021: https://forms.gle/MgAtFCgqRDdqyWKM7 We are […]
Read MoreGreenlight Guru Summit December 8th: Let’s get back to Auditing, REMOTELY!
If you’re a medical device professional looking to prepare for the new year, join us at The 2021 State of Medical Device Virtual Summit Dec. 8-9th. Our very own Nicolle Cannon is leading a session at this Greenlight Guru event: “Let’s get back to Auditing, REMOTELY!” The summit is 100% virtual and 100% FREE. REGISTER […]
Read More6 Tips for Remote Auditing
The year 2020 will mark a shift in auditing toward wider use of technology replacing onsite face-to-face interaction. As with any shift, there are early adopters and those who lag. Cannon Quality Group has helped many clients through remote audits from notified bodies, and has conducted many supplier audits remotely on behalf of our clients. […]
Read MoreMaster Control Summit 2020 Breakout Session 10/20
Catch Nicolle Cannon, CEO of Cannon Quality Group, as she advises medical device companies on EU MDR and IVDR on October 20th at the Virtual Master’s Summit 2020 hosted by MasterControl: https://bit.ly/2SJdGRM
Read MoreTop 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. Check out our new resource stacking up the best for collaboration, design controls, document controls, audit management, analytics and reporting, and more in one easy to […]
Read MoreLimFlow – 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 […]
Read MoreShared 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 […]
Read MoreDo 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 […]
Read MoreCannon 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. […]
Read MoreHow 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 […]
Read MoreMedical 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, […]
Read MoreCannon 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. […]
Read MoreVerily 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 […]
Read MoreInterview 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 […]
Read MoreCase 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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