Digital transformation
Digitization is reshaping the medical device industry. Innovation is increasingly driven by artificial intelligence (AI) powered and cloud-based smart digital health applications, software as a medical device (SaMD), or the internet of medical things (IoMT).
To keep up with the dynamics introduced by software-driven innovation, new approaches are needed for medical device design processes and post-market surveillance that demonstrate software engineering excellence and regulatory compliance.
A digital ecosystem for medical devices
To help shorten time to market, leading medical device manufacturers have successfully adopted software-centric development approaches.
The image shows key topics that influence and improve medical software design. Instead of keeping those initiatives separated, a holistic systems engineering approach is needed.
Process management for medical devices
Stages is a proven platform for creating and rolling out integrated process landscapes that cover the essential aspects of medical software design.
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.
Regulatory support
Stages has unique capabilities to help significantly reduce the efforts for demonstrating compliance to regulations and industry standards.
It helps engineers navigate the complex and evolving regulatory landscape for medical devices, including the following regulations and standards:
- U.S. Food and Drug Administration (FDA) Code of Federal Regulations (CFR) Title 21, Part 820.
- European Union (EU) Medical Device Regulation (MDR)
- International Electrotechnical Commission (IEC) 62304, Medical Device Software — Software Life Cycle Processes.
- International Organization for Standardization (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 81001-5-1:2021, Health Software and Health IT Systems Safety, Effectiveness and Security, Part 5-1: Security — Activities in the Product Life Cycle.
- 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
Engineering excellence
Leverage the experience of our engineers and consultants to achieve systems and software engineering excellence for your medical devices.
Here is a sampling of our areas of expertise:
- Medical software and systems development.
- Development of medical software according to IEC 62304.
- Implementation of risk analysis according to ISO 14971.
- Implementation of usability engineering processes according to IEC 62366.
- Support in the setup of software development processes to fulfill regulatory requirements efficiently.
- Agile development of active medical devices according to Association for the Advancement of Medical Instrumentation® (AAMI) Technical Information Report 45 (TIR45).
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