Launch Packs For New Customers

If you’re a new customer and want to get your quality system up and running as soon as possible, Launch Packs are for you.

Get everything you need to ensure your quality management system and regulatory compliance don’t become the focus of your business


Full QMS Support

We’ll help you design and implement a QMS that fits your business, and we’ll provide you with QMS procedures, forms and templates that will save you time and help make audits smoother.


Training, Strategy, and Guidance

We’ll help you and your staff with regulatory submissions, and we’ll provide training in design controls, risk management (ISO 14971), and QMS (ISO 13485 & FDA 21 CFR Part 820).


In-House Support

With any Launch Pack, our experienced in-house team becomes an extension of your quality and regulatory team. You’ll have everything you need to remain focused on your product and business.

Launch Packs

You can purchase Launch Packs alone, or you can combine it with a Customer Success & Professional Services package for additional support.

Boost Package

This package is for you if:

  • You are implementing a QMS at your company for the first time, or looking to revamp your current QMS.
  • You want access to audit-tested procedures, forms and templates that will save you a ton of time and headache during audits and inspections.
  • You want our in-house team to help with the implementation and customization work.
  • You have some medical device regulatory expertise on staff (if not, consider the Boost Plus Package).

Boost Package Includes:

  • Full QMS procedures, forms and templates that you’ll need at every stage of QMS implementation process. These resources are proven, audit tested, and build out your QMS.

Boost Plus Package

This package is for you if:

  • Your team is inexperienced in regulatory processes, or you prefer to outsource staff training to us.
  • Your want our in-house team to become an extension of your regulatory and compliance team.

Boost Plus Package Includes:

  • Everything in the Boost Package, plus...
  • QMS customization and implementation
  • ISO 13485 QMS training (remote-based)
  • FDA 21 CFR 820 training (remote-based)
  • ISO 14971 Risk Management training (remote-based)
  • Applied Design Controls training (remote-based)
  • Applied Risk Management training (remote-based)

Schedule your free call to learn more about Launch Packs and to have any questions answered.

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Next: Learn about Customer Success & Professional Services packages that you can combine with a Launch Pack for additional support