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Medical Device QMS Implementation, Simplification & Compliance

Do you need to set up a complete quality management system for your emerging medical device/IVD company?  Do you feel like your existing QMS is overly burdensome and complicated for your business?  A simpler system may help reduce costs and compliance issues.

If you need help implementing, simplifying, or maintaining a quality system for your medical device or in vitro device, look no further than Cannon Quality Group. Our quality team has a passion for keeping things simple and risk-based, and we have years of experience helping MedTech startup companies reach their business goals no matter what stage of the product life cycle they’re in.

To learn more about our QMS implementation and maintenance services, contact us online today.

Our Medical Device Quality Management System Solutions

Since 2010, we’ve offered our services to MedTech startup companies who needed simple, risk-based systems to meet regulatory requirements for design control, internal audits, supplier controls, validations, and more. We help find the right-sized QMS to enable you to get more done, simpler, and faster! We’re sensitive to the fact that every company has different needs depending on their stage of development and business goals. Some of our services include:

  • Document control – Our team can help you develop effective procedures for document creation, filing, review, and more.
  • Design control – Prove that your medical device is safe and meets the needs of your target consumers with effective design control practices. This is the best opportunity to confirm your device can be produced consistently to your high standards, before having to experience major production issues.
  • Audits – We offer both internal and supplier audits to help you improve your quality system to meet regulatory requirements and make you aware of your supplier’s quality system capabilities.
  • Risk management – In accordance with ISO 14971 and ISO 9001:2015, risk planning when developing a QMS has shifted to being more proactive. This means planning and designing an effective risk tolerant quality system has never been more important.
  • Production control – The last opportunity to ensure your device is safe and effective. We recognize that the right process checks will save a lot of hidden costs.
  • Complaint management – Cannon Quality Group can help your company develop a valuable complaint management system that will help log, evaluate, and act on customer complaints quickly and purposefully, including assessing medical device reporting requirements.
  • Ongoing QMS maintenance – We can maintain your quality system in many areas, including your ASL for supplier controls and certification, monitoring CAPAs, NCMRs, and preparing documentation and statistics for your regular management reviews.
  • And more

View our full list of services here. If you or your medical device/in vitro device company needs assistance developing and implanting any portion of a quality management systems listed above, contact Cannon Quality Group today.

Medical Device Quality System Compliance

Our company’s mission is simple:  getting safe medical devices and in vitro devices to patients with simple, risk-based quality systems.  We are excited to have had the opportunity to work with so many companies and bring new technology to the marketplace. We’ve helped many of these companies achieve their business goals while maintaining the level of quality compliance needed to earn certifications and pass industry standards, and we can help you as well. We have experience with medical device quality systems to achieve compliance for the following regulations, standards, or organizations:

  • FDA
  • Sherman Law (California FDB)
  • Medical Device Directive
  • ISO 13485
  • ISO 14971
  • IEC 60601
  • IEC 62366
  • And more

If your medical device is in need of a QMS you can rely on, contact Cannon Quality Group. We can also perform QMS maintenance to ensure that your system is up to date and meets all necessary regulations.

Choose Cannon Quality Group for Medical Device QMS Solutions

When you need professional assistance developing, tweaking, or maintaining your quality management systems, call Cannon Quality Group. We have the passion, resources, and experience to provide audits, gap assessments, and whatever else you need to reach your business goals.

Contact Cannon Quality Group today!

What Our Customers Have to Say

“For our startup, CQG made QSR development and compliance enjoyable and easy. Their unique style and system have allowed us to work at the fast pace required by the market, while still maintaining regulatory compliance.”
– Andrew Hosford, Director of Engineering – Gauss Surgical

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Testimonials

"The shared audit program allows us to meet the needs of our supplier auditing procedure without having to schedule individual site audits; this saves us time and resources while enabling us to maintain compliance with the requirements of our quality management system."

-Scott Sershen/BlackSwan Vascular, Inc. Hayward, CA

"I am working on aging and packaging which they specifically said was assigned based on my experience at Cannon. Your internship program is literally the gift that keeps on giving."

-Maggie Baker/R&D engineer intern, former CQG intern from California Polytechnic State University, San Luis Obispo, CA, now at a major medical device manufacturer.

"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, Santa Clara, CA and Paris, France

"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., Emeryville, CA

"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, Marlborough, MA

"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., Los Altos, CA

"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., Hayward, CA

"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., Sunnyvale, CA

"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, Seattle, WA

"It was by far the best QSR/GMP training – high caliber content and engaging delivery."

-Robert Angelopoulos/Sr. Engineering Manager, Powervision, Inc., San Mateo, CA

"Don’t stress. Call Cannon Quality Group for great project support."

-David Freed/Sr. Quality Director, AcelRx Pharmaceuticals, Inc., Redwood City, CA

"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, Fremont, CA

"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, Mountain View, CA

"Our [CQG] auditor provided findings with value-based explanations and implementation ideas."

-Kyle Dion/Quality Specialist, BlueLine Sterilization Services, Novato, CA

"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, San Francisco, CA

"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, San Francisco, CA

"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, Irvine, CA, Leeds, U.K. and Munich, Germany

"Your team is great, love the maturity level. Great respect from Quality & Regulatory."

-Mark Adler/Senior Director of R&D JenaValve, Irvine, CA, Leeds, U.K. and Munich, Germany

"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., Emeryville, CA

"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, San Ramon, CA

"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, Menlo Park, CA

"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, San Mateo, CA

"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., Los Altos, CA

"Pete is awesome, I appreciate the help he provides to our team and his assistance in various quality needs."

-Kityee Au-Yeung/Profusa, Emeryville, CA

"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, Palo Alto, CA
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