Product Design Processes for Medical Devices

Digital Transformation

The global digitization is reshaping the medical device industry. Innovation is increasingly driven by AI-powered and cloud-based smart digital health solutions, Software as a Medical Device (SaMD), or the Internet of Medical Things (IoMT).

To keep up with the dynamics introduced by software, a new approach for medical device design processes and post-market surveillance is needed, which reaps the benefits of digitalization while still being compliant to regulations.


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A Digital Ecosystem for Medical Devices

To shorten time-to-market, leading medical device manufacturers have successfully adopted “software first” development approaches, e.g.

  • DevSecOps: Manage cybersecurity risks continuously as part of the development and operation processes (DevOps) rather than an afterthought.
  • Agile: even in the regulated medical device environment, agile development practices can be used to faster respond to changing market requirements and conditions


The image shows typical initiatives for digital product design. All of them have strong impact on the processes described in the quality management system (QMS). However, current document-centric QMS are too static to keep up with the new dynamics introduced by software. Successful design and operation of digital medical devices requires a new process approach.

Our Solution


Stages is the proven platform for transforming the QMS from a static document library to digital model-based processes.

Stages helps to speed up product launches by

  • modeling streamlined development processes
  • accelerating adoption of new practices and techniques
  • tearing down silos between design teams


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Regulatory Support

Stages has unique capabilities to map processes onto regulatory requirements which reduces the efforts for proving compliance by over 50%.

It allows to successfully navigate the complex and evolving regulatory landscape for medical devices, including

  • FDA 21 CFR 820
  • EU MDR
  • IEC 62304: Medical Device Software — Software Life Cycle Processes
  • ISO 14971:2019, Medical devices — Application of risk management to medical devices
  • ISO 13485:2016, Medical devices — Quality management systems — Requirements for regulatory purposes
  • IEC 82304-1: Health software — Part 1: General requirements for product safety
  • IEC 81001-5-1
  • FDA Guidance: Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions
  • ISO 27799: Health informatics — Information security management in health using ISO/IEC 27002

Interview with Siemens Healthineers

Stages is useful in getting people together, harmonizing our processes and identifying ways for our engineers to work as optimally as possible.

Shamron Awwal, Senior Process Engineer, Siemens

On Demand Webinar

Digital Transformation of Medical Device Design Processes


What you will learn:

  • The impact of digital transformation on design processes for software-intense medical devices
  • How to manage the dynamics of software from regulatory compliance perspective
  • The advantages of a fully model-based approach replacing the static process documentation in MS Word and Excel


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