Outsourced Medical Device Quality Control & Assurance

MedTech QMS Outsourcing Solutions in the San Francisco Bay Area & Beyond

Developing and managing proper quality guidelines for your medical devices is imperative. Not only will it ensure your company’s ability to abide by the rigorous guidelines set forth by various organizations, but it also ensures your product is safe for clinical use.

While quality control and assurance are important to your company’s success, we understand that it isn’t your core business. We also know you don’t want individuals that are vital to your organization spending their time on quality control. An overly burdensome quality system or an inappropriately staffed quality department drains away resources that are critical to achieving your business goals and market success.

Here at Cannon Quality Group, we help startup medical device companies avoid these problems. By outsourcing your quality system management functions to our team of quality specialists, you can rest assured that your company will receive the most up to date and technically sound QMS solutions available.

Though located in California, Cannon Quality Group can develop and implement quality management systems for medical device companies across the United States. Contact us online today to learn more about our QMS services.

Quality Management System Outsourcing Services

We pride ourselves on providing our clients with passionate service that results in a quality finished product. When you choose our quality assurance and compliance team, you’ll receive insights, guidance, and perks that are specific to your product. Some of these include:

  • The right-sized quality system given your product class, organization size, organizational stage, and business objectives
  • On-call access to a full quality team without the cost burden of paying for your own full-time quality department
  • The ability to align the right quality system tasks to quality team members who possess the knowledge and skill set to make things more efficient and effective

By outsourcing your quality needs to a team that has years of experience in the medical device industry, you allow key employees in your organization to focus on other tasks, avoid struggling or worrying about your quality management systems, and also save money in the long run.

Outsourcing all of your quality systems can lift a weight off your shoulders. Contact Cannon Quality Group online now.

Choose Cannon Quality Group When Outsourcing Quality Services

If you’re looking for a way to develop and implement a QMS, outsourcing to Cannon Quality Group is easier than recruiting, hiring, training, and managing the quality function yourself.

Our outsourcing services will give you direct access to an entire quality department, which includes all levels of quality engineers and quality assurance support team members. Each member of our team has experience in the industry, so you know you’re getting advice and guidance from the best. In addition to other roles such as document and supplier control, Cannon Quality Group also has a team of experienced auditors on staff who are available to perform both internal and supplier audits.

Whether you’re preparing to earn your ISO 13485:2016 certification, FDA approval/clearance, or simply tightening your internal quality strategies, Cannon Quality Group is the name to remember. By outsourcing all functions of your quality approach, you’ll receive simple, risk-based solutions from a passionate quality team.

Schedule a conversation with the medical device QMS specialists at Cannon Quality Group today.

See What Others Have to Say

“Cannon Quality Group has been instrumental in keeping our quality management system in regulatory compliance while staying synchronized to our size and stage of corporate development. We have benefited from CQG’s expertise in internal auditing, protocol development, corporate ISO training, Management review oversight as well as Quality Assurance representation during external regulatory inspection. This speaks volumes to the breadth and depth of experience they have to offer.”
– Bill Beasley, President and COO – Neodyne Biosciences

Testimonials

"I just wanted to drop a quick note to thank you all for your support over these past several months. We had a very successful audit this week. Both auditors were very complimentary of the progress we have made since the last audit and that is really a testament to…"

-Zachary Woodson/Vice President of Regulatory Affairs & Quality, LimFlow SA

"Look what you have done!  Profusa has a functional QS thanks in large part to you. The GMED auditor has conducted over 700 audits and said we have an extremely good QS and a lot of that credit goes to you… I just wanted to let you know that Profusa…"

-David Hesting/QA Director, Profusa, Inc.

"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
Need a Controlled Environment?
/* */