Qase3D can provide you with a fully digital Quality Management Sytem, or eQMS, based on ISO 13485:2016.

  • No paper-based QMS
  • No Word documents
  • No dedicated QMS software system

A paper based QMS can no longer comply with the requirements for document control as defined in ISO13485

Dr. ir. Erik Boelen

Collaboration platform

eQMS is built in a popular software for team collaboration, which is simple and elegant and therefore easy-to-use. It completely eliminates the need for (and hassle with) paper or Word-based procedures and forms. It has built in versioning and permissions. It works in the cloud, but can also be run on a local server.


The QMS is fully customizable to your company’s scope and activities. It is especially suited for start-ups / scale-ups in additive manufacturing (3D printing) of (custom-made) medical devices.

Documented procedures and forms

eQMS is complete with:

  • Quality Manual
  • Quality Policy
  • Quality Objectives
  • Company Procedures

and also comes with convenient form templates:

  • Management Review
  • Non-conformities
  • Feedback
  • CAPA’s
  • Audit

A living Quality Management System

Because eQMS works inside a team collaboration platform, employees are (probably) using the platform on a daily basis and as a result eQMS is more accessible and becomes part of their workflow.

eQMS becomes a “living QMS” that works for the people, rather than being a bureaucratic burden!


Obviously, Qase3D can support you with the customization and implementation.

Let Qase3D kickstart your QMS towards ISO 13485 certification! The sooner you start with a Quality Management System, the easier it is to implement.

Your QMS is much more advanced than that of bigger companies I’ve audited

Ronnie | External Auditor