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.