Supplier Audits for Medical Device Quality Management
As a startup medical device, MedTech, or in vitro device company, you and your team are facing a myriad of regulations and standards your device must meet before you launch. Finding and implementing an effective quality management system can be a burden, especially when that time could be spent on more mission-critical tasks. That’s where Cannon Quality Group comes in.
Use your time efficiently and hire a company that has years of experience providing quality management system solutions. Cannon Quality Group was built to aid those working in the MedTech industry who are frustrated with ineffective or cumbersome QMS methods. By outsourcing your medical device vendor audits to our quality control team, you can rest assured you’re making a wise cost-effective and time-saving decision.
Medical Device QMS: Private Supplier Audit
Private supplier audits are conducted just for you and your requirements. Our professional auditors have years of experience compiling and creating informative reports that identify all elements and potential form 483 or CAPA issues. The results of the audit are not made available for purchase by other firms.
If you need a private medical device vendor quality audit completed, call Cannon Quality Group today. Contact us online and let us worry about developing effective quality management system solutions so that you can focus on the growth and development of your product.
Medical Device QMS: Shared Supplier Audit
Another great way to save even more time and money on quality control services is to invest in a Cannon Quality Group shared supplier audit. These audits can save you 30 percent or more by sharing the cost of the auditor’s time and travel expenses across many other companies and medical device manufacturers that also need their supplier to be audited.
There are two types of shared supplier audits available for our customer to access and review:
Our planned shared supplier audits have yet to be completed and are available for you to purchase. Review our list of planned audits to see if your supplier is listed.
If you have a supplier that is not on the completed list or need a more customized audit, then contact us today and discuss the most efficient way to have all your supplier audits completed. We’ll work with the supplier to find other companies and firms looking for shared audits so you’re still able to take advantage of the financial flexibility a shared supplier audit provides.
If you review our completed audits page, you can see a list of medical device suppliers we’ve already inspected. These completed audits make launching your product even easier, as all the information regarding your specific medical device part supplier is already prepared and compiled in a clear, concise report.
Medical Device Quality Management Systems
Through our detailed medical device supplier audits, we’re able to ensure your suppliers adhere to the relevant standards and regulations of different institutions, including:
- ISO 13485:2016 – The ISO 13485 is the guiding standard of quality assurance in the realm of medical devices. Trust Cannon Quality Group to inspect and confirm your suppliers live up to the regulations. Become ISO certified and allow your product to earn its CE mark today.
- FDA Quality System Regulation – Ensure your suppliers abide by the strict regulations set forth by the FDA. According to Code of Federal Regulation Title 21: Part 820, manufacturers are “required to develop and maintain procedures that ensure all purchased or otherwise received products and services adhere to a specific set of requirements,” so the quality of your supplier’s components ultimately falls under your company’s responsibilities.
- Custom requirements – If your device or product expects or needs a specific level of quality from your suppliers, Cannon Quality Group can deliver custom reports and audits that satisfy your requirements and will help you manage your quality management system.
Trust Cannon Quality Group to verify your vendors through a medical device supplier audit using our proven quality management systems. To learn more, contact Cannon Quality Group online today.
Choose Cannon Quality Group for Medical Device Supplier Audits
Thanks to our years of experience in the medical device/MedTech/IVD industry, Cannon Quality Group is ready to help your company create and establish effective quality management systems, beginning with the audits of your suppliers. Whether they are private or shared, we offer a professional approach that can satisfy any company’s needs.
Contact us to learn more about our medical device auditing process and speak to our medical device quality experts.