services

Device Compliance Essentials for Startups

If you’re an entrepreneur in Medtech, IVD or software as a medical device (SaMD), you’ll want to set the stage for compliance early on, and Cannon Quality Group has a new cost-effective program to get you there.

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.

Modules:

  • Design and Development
  • Doc control
  • Material Controls
  • Nonconforming materials
  • Purchasing
  • Risk Management
  • Software Development
  • Supplier Quality
  • Training

This DIY program gives you access to tried-and-true procedure templates in each of these areas, as well as a monthly call-in opportunity to ask Cannon Quality Group’s quality management experts questions that might arise along the way.

For only $500/month, you can set up your own compliant early-stage QMS, covering the essential elements of pre-commercial activity and developing institutional muscle for heavy lifting later.

You can choose the order of the SOPs you’d like to develop to match when you need it. For example, when you see you need to start training people, you can download the training template. Or the supplier quality template when you need to start managing suppliers.

Sign up today to get started. We’re looking forward to supporting your venture.

Pricing

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

*Cannon Quality Group accepts major credit cards

Contact Us About Device Compliance Essentials for Startups

Quality Management Services

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