Cannon Quality Group

Resources

Case Studies

North Coast Medical: A Case Study in Regulatory Compliance

Learn how Cannon Quality Group helped the company resolve compliance issues ASAP so they could continue to ship products and not be shut down.

Theravent: A Case Study in Quality Assurance & Compliance

Client needed rapid response firepower in quality assurance to match the speed of change in other operational areas of the company, and to streamline their quality management system (QMS) fast.

Audit Efficiency Program

Completed Supplier Audits for purchase

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Steri-Tek

Fremont, CA  |  May 6, 2022
$2300.00

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Steri-Tek

Fremont, CA  |  May, 2021
$2300.00

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Blue Line Sterilization Services

Novato, CA  |  November, 2021
$2300.00

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Nelson Labs

Salt Lake City, UT  |  May, 2021
$2300.00

Device Compliance Essentials for Startups

Device Compliance Essentials for Startups is a program aimed at early-stage, pre-commercial Medtech, IVD and SaMD startups that need procedures covering key aspects of early activity in a concise fashion. The majority of FDA Quality System (QS) regulations and ISO 13485 medical device requirements address processes and procedures for post-product development, which means you can get a QMS set up for your pre-commercial enterprise with a modest amount of effort.

Device Compliance Essentials for Startups Standard

$3,600 ($600 per month for 6 Months)


Benefits:

  • 3 Getting Started Templates
  • Document Control
  • Product Design & Development
  • Software Development
  • 3 Mitigating Risk Templates
  • Purchasing
  • Risk Management
  • Training
  • 3 Ensuring Quality Assurance & Control Templates
  • Material Control
  • NonConforming materials
  • Supplier Quality
  • 6 Monthly 60-Minute Access to Group Meetings with a Quality System, Assurance, Audit, or Control Expert

Device Compliance Essentials for Startups Pro

$6,000 ($1,000 per month for 6 months)


Benefits:

  • 3 Getting Started Templates
  • Document Control
  • Product Design & Development
  • Software Development
  • 3 Mitigating Risk Templates
  • Purchasing
  • Risk Management
  • Training
  • 3 Ensuring Quality Assurance & Control Templates
  • Material Controls
  • NonConforming materials
  • Supplier Quality
  • 12 Bi-Weekly 30-Minute Access to Personal Meetings with a Quality System, Assurance, Audit, or Control Expert

eBooks

ISO 9001:2015 & ISO 13485:2016 for Medical Devices: A Definitive Guide

A definitive guide to helping you coordinate and direct your organization’s product development activities to meet customer requirements and improve effectiveness and efficiency on a continuous basis.

Risk Management Process; Medical Device Best Practices & Requirements to Control Risks to Users, Patients, and the Environment

Incorporating a solid Risk Management Process can not only mitigate regulatory risk but also deliver peace of mind to all stakeholders in the enterprise as they launch new medical device products.

Templates

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GSPR

General Safety and Performance Requirement (GSPR) applies to medical device regulation. Cannon Quality Group offers a template to help our clients streamline the GSPR process.

$349.00

Webinars

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A QMS Paradigm Shift: eQMS in Medtech Today with Dot Compliance

In this webinar, Cannon Quality Group CEO and founder, Nicolle Cannon, along with Mickey Landkof, GM of Dot Compliance North America will discuss how new technologies and deployment methodologies are replacing traditional and legacy QMS implementations. You’ll learn how to successfully approach a QMS implementation, how regulatory compliance is achieved, and see the advantages and latest features of Dot Compliance’s ready to use solutions. (2022)
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Navigating eQMS in Medtech Today with Enzyme

Learn how to navigate not only when you might need to implement an electronic quality management system (eQMS) but also the advantages and latest features of Enzyme. (2021)

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Navigating eQMS in Medtech Today with Greenlight Guru

The use of electronic Quality Management Systems (eQMS) are becoming standard technology in Medtech startups. They offer the promise of automation, improving compliance, reducing cost, increasing productivity, enhancing traceability, and reducing documentation burden. In this webinar in our series, Cannon Quality Group CEO and founder, Nicolle Cannon along with Wade Schroeder, Greenlight Guru Medical Device Quality Consultant, will discuss how new technologies and deployment methodologies are replacing traditional lengthy, costly and complex QMS implementations to help you navigate not only when you might need to implement an electronic quality management system but also the advantages and latest features of Greenlight Guru.

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Navigating eQMS in Medtech Today with Dot Compliance:

In this fourth webinar of our quarterly series on Navigating eQMS platforms, Cannon Quality Group CEO and founder, Nicolle Cannon along with Mickey Landkof, GM & VP of Sales at Dot Compliance, will help you navigate not only when you might need to implement an electronic quality management system but also the advantages and latest features of Dot Compliance.

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Navigating eQMS in Medtech Today with MasterControl:

Learn how to navigate not only when you might need to implement an electronic quality management system (eQMS) but also the advantages and latest features of MasterControl.

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Navigating eQMS in Medtech Today with Enzyme:

Learn how to navigate not only when you might need to implement an electronic quality management system (eQMS) but also the advantages and latest features of Enzyme. (2020)

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Greenlight Guru 2020 Summit:

Audits Let’s get back to Auditing, REMOTELY! Learn both the hard skills of getting comfortable with various technology platforms as well as the soft skills of effective communication between auditor and “auditee.” Many now predict remote auditing will remain the default option in the coming years.

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Refocusing on the European Union’s Updated MDR/IVDR Regulations:

While medical device manufacturers have been given an additional year to prepare for new European Union regulations, pivots in business and an altered timeline for Medical Device Regulation may drive the need to comply sooner.

Resources our clients have used:

Steri-Tek

Steri-Tek is a high-volume E-beam/X-Ray contract sterilizer and R&D innovation center serving the medical device, biotech, allograft tissue, pharmaceutical and other industries.

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BioTransitions LLC

BioTransitions LLC provides organization strategy and planning, change management, strategic outsourcing, and fractional leadership to emerging and commercial firms in pharmaceuticals, biologics, and medical devices.
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Triermain, LLC.

Triermain, LLC. is a Puget Sound-based company providing professional consulting services in the areas of image-guided surgery, medical and scientific lasers, biophotonics, optics, fiber-optics, remote sensing, life sciences and metrology.
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CAI

We help our customers design, deliver, operate and maintain quality-critical manufacturing (GMP related) or mission-critical facilities. Our engineering, technical and consulting services encompass all aspects of operation: equipment, automation, process, human performance. The result is a superior level of operational performance and reliability.
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UCSF Rosenman Institute

The UCSF Rosenman Institute is a public-private healthtech accelerator, based at UC San Francisco, which assists entrepreneurs commercializing new technologies in diagnostics, digital health, health services and medical devices.
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Medical Murray

Medical Murray is an FDA registered and ISO 13485 certified contract manufacturer with multiple locations in the US. We provide design, development, testing, and manufacturing services with expertise in complex catheters, implants, and delivery systems.
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Cannon Quality Group (CQG) was founded in 2010 as a full-service outsourced quality management company serving the medical device, Medtech, pharma, IVDR, SaMD, and general life science community with right-sized quality management system solutions.

Contact

(925) 944-9468

Cannon Quality Group, LLC
77 Front Street
Danville, CA 94526