Supplier Audits for Medical Device Quality Management

As a startup medical 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.

View our completed medical device supplier auditsaudits we have planned, or contact Cannon Quality Group online to discuss how we can help launch your product faster, today.

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:

Planned Audits

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.

Completed Audits

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.

See the All Suppliers Audited list to get a sense for the breadth and scope of our auditing services, and contact us online for more details.

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 MedTech 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.

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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