FDA QSR Compliance

Cannon Quality Group Offers Audits & Training to Ensure Your Device is Ready for FDA Approval or Clearance

At Cannon Quality Group, we take a simple, risk-based approach to QSR compliance and FDA clearance. Whether your startup MedTech company requires support for an audit or you wish to tighten your company’s QMS to stand up to the scrutiny of the FDA, you can count on Cannon Quality Group.

Contact Cannon Quality Group today if your product needs help becoming FDA- or QSR- compliant.

Who Needs FDA Clearance & Approval?

The Food and Drug Administration regulates all medical devices marketed in the United States. As such, it’s imperative that your processes and procedures conform to FDA’s quality system regulation guidelines. The FDA has also announced its intention to use ISO 13485 as the basis for its quality system legislation.

The exact quality requirements for medical devices are listed in Title 21, Part 820 of the U.S. Code of Federal Regulations. This document depicts the responsibilities of medical device providers in regards to packaging, labeling, storage, and other components of the product.

To ensure your medical device is up to the FDA’s standards as well as ISO 13485:2016, contact the quality management professionals at Cannon Quality Group today!

Our FDA QSR Compliance Services

Our founder created Cannon Quality Group after spending years in MedTech engineering. Our quality management company was born to help medical device companies create simple, risk-based QMS solutions that give quality managers an easy, useful, and efficient tool instead of forcing them to rely on a fear-based strategy.

To accomplish this, we’ve developed a multitude of strategies and services that help companies succeed and become compliant with different standards, including those set by the Food and Drug Administration and the ISO 13485 standard. These include:

  • FDA mock audits – Using the same standards set by the FDA, our experienced auditors can evaluate your product procedures and determine what areas of your quality management system need to be updated or modified
  • Gap analyses – As standards evolve over time, many clients ask us to perform a gap analysis, where we determine where they are today, where they need to be or will soon need to be, and the steps to close the gap.

Although the requirements laid out in Title 21, Part 820 of the U.S. Code of Federal Regulations may be somewhat cryptic and difficult to implement at first, the team at Cannon Quality Group has the experience and knowledge to help your product develop quality management systems that fulfill each QSR quality subsystem, including management controls, design controls, corrective and preventive actions, and product and process controls.

The quality system regulation maintenance experts at Cannon Quality Group can help ensure you meet the QSR compliance requirements necessary to meet the expectations of the FDA. Contact us online to let us know how we can help on your device’s QSR compliance journey.

Choose Cannon Quality Group for Medical Device QSR Compliance Services

Though based in California, our quality team is able to provide FDA QSR services for startup medical device companies all over the United States.

If you’re concerned or confused about the FDA clearance approval process for medical devices, entrust the quality management solutions team at Cannon Quality Group to shed some light on the subject and get your product to market — fast.

Contact Cannon Quality Group for more details regarding our services. Also, be sure to learn about our Founders Club memberships, which give companies access to a controlled environment room, tools, lab equipment, and more.

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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