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Stages for Medical

Mastering the processes, i.e. enhancing productivity while at the same time complying with all the relevant regulations, has for a long time now been a challenge in the development of medical devices and systems.

The "Unified Process" test case - now available together with the "Stages for Medical" edition!

Unified Process supports you in gaining company certification according to ISO 9001 and ISO 13485 or concerning the Quality System Regulation (QSR according to Part 820) as well as with product accreditations. It comprises the full life cycle: from a preliminary study to successfully placing your medical products on the market. Unified Process contains all the processing instructions, forms and templates you need to make the authorisation of medical equipment much simpler.

With Unified Process you develop your products in conformity with the relevant international norms and regulations (EU & FDA). Use Unified Process together with the Stages for Medical process management solution that has been optimised for the medical technology sector. You will not only gain by always conforming with standards and norms in your work: with Stages Report you can also evidence conformity to an auditor at the push of a button and at any time.

You benefit from the Unified Process:

  • Complete, ready-for-use and validated process landscape
  • Reliablity and assurance  for certification and accreditation proved by multiple successful accreditation of new medical devices
  • Securing early market access with an orderly, predictable system of project management

Benefit from the Unified Reference for Medical Software:

  • Enormous reduction of the regulatory requirements through summary and interpretation of overlapping regulations
  • Always up-to-date through upgrade service
  • Automated gap analysis after upgrading to new versions of included norms and standards
Stages for Medical, Unified Process, Unified Reference

Benefit from Stages for Medical:

  • Comfortable implementation of the Unified Process in a practice-oriented way
  • Quick and simple adaption of the process and contained parts through process modeling and tailoring
  • ...and all additional Stages BENEFITS

We can help you resolve this complexity by:

  • Interpreting, summarizing, and modeling pertinent standards in clear, actionable system development steps. (Unified Reference)
  • Visualizing your processes with views that automatically adapt to changes.
  • Reviewing legacy processes to ensure compliance with standards.
  • Tailoring processes.
  • Conducting automated GAP analyses to follow up adaptations to conformance changes.
  • Managing development projects in accordance with compliant processes.

Customers

Siemens Healthcare, NewTec, TomTec

Partner

  • Optana - Stages Content Partner
  • QCompetence - Implementation Partner

You would like to learn more?

Get your individual quotation for Stages. Request quote
Use Stages one month for free! Register now
Register for a webinar and get a more detailed insight in a individual Q&A session! Register now for webinar

Any Questions?

If you have questions about our product offers, feel free to call us!

Call:
+1 284 605 1419