Medical Device QMS Services

Helping you attain and maintain quality system compliance with FDA, Sherman Act/CAL FDB, Medical Device Directive, ISO 13485, ISO 14971, IEC 60601, IEC 62366, and IEC 62304 is our area of expertise.

We believe that there is no “one size fits all” quality management system. Product class, organization size, organizational stage, and business objectives must be considered in order to implement the right-sized QMS solution. That’s why at Cannon Quality Group, we offer a multitude of different services to help our customers’ products meet every guideline and standard.

Contact us to learn more about our medical device quality management solutions or to speak to our medical device quality experts.

Our Quality Management Services

ISO 13485:2016 – If you’re in the MedTech industry, you know you must comply with the rigorous standards set by different organizations. The ISO 13485:2016 is specific to medical devices and imperative for products going to market. By having your device meet all the requirements set by this standard, you can be sure your medical device will meet the extensive safety and performance requirements for consumers, suppliers, and more.

Supplier audits – A Cannon Quality Group shared supplier audit can save your company up to 30 percent by splitting the auditor cost with other companies needing the same information. CQG can also perform supplier audits on short notice for clients who find themselves in a pinch.

Internal audits – Regular auditing of your internal processes and procedures is a cornerstone of good quality management. You can meet your requirements for internal auditing more easily by hiring Cannon Quality Group’s experienced auditors to come in and give you a fresh perspective on your quality system or perform a gap analysis.

QMS implementation and maintenance – Allow our quality team to fine tune your medical device’s QMS system. We’ll implement a simple, risk-based system while you focus on other mission-critical tasks for your company.

Quality projects – Cannon Quality Group is comprised of experts who can mesh with your company’s workflow and goals to help you complete quality projects such as ERP implementation, post-audit remediation, and more.

Controlled environment room (CER) – If you are considering building a Controlled environment room at your facility, Cannon Quality Group can help you every step of the way up through validation to ensure your room is compliant with all relevant requirements. If you’re looking for a CER in the meantime, we maintain our own CER in Redwood City, CA.

Founders Club memberships – When you become a member of Cannon Quality Group’s Founders Club, you’ll gain access to our shared space facility which is equipped and ready for testing. Complete with a controlled environment room, this area offers storage space, a CDA system, lab benches, and is ISO Class 7–certified.

Find out more about our Founders Club memberships today by contacting us online.

FDB certification/audits – When you need a quality management system that meets the standards of the California Food and Drug Branch, you can count on Cannon Quality Group. Whether you need to prepare for certification or require a professional audit to completely review your current quality system, we can be of service.

First in human – To prepare for such a milestone, you must first secure IDE approval (Investigational Device Exemption), which requires quite a bit of documentation. Cannon Quality Group helps you navigate the proper documentation and will ensure that you have what is necessary for approval.

FDA audits/FDA clearance/QSR compliance – Are you ready to file your submission and want to ensure you have a quality system in place that can stand up to the scrutiny of the FDA? Cannon Quality Group is well versed in the rules and guidelines set forth by the Food and Drug Administration and can help make sure your product and quality system are up to code.

Complete outsourcing – While quality control and assurance are important to your company’s success, we understand it is not your core business. Cannon Quality Group represents a chance for you to have the most simple, effective QMS procedures in place without having to hire your own department. We can take on entire projects and also offer interim and part-time staffing options.

Choose Cannon Quality Group for QMS Solutions

Whether your medical device startup company requires a controlled environment room for additional testing or supplier audits to the ensure the quality of your medical device, you can count on Cannon Quality Group for outsourced quality management solutions.

Contact us online or call us today to learn more about our quality management systems solutions.

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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