Medical Software Processes
A multitude of laws, regulations and established standards apply to the development of medical devices. Particularly in dynamic software development, you need a development process that complies with regulatory requirements and still reacts flexibly to the changing demands in the market.
The work products a process must deliver are just as important as the acceptance of the process users.
The goal is to provide the most agile software development process possible that remains responsive to changing requirements and to minimize the manual overhead to bring your medical device to market in a manageable timeframe.
With professional support ...
- your software development process is state-of-the-art
- you meet the requirements of established standards and applicable regulations
- you respond dynamically to changes, without friction loss
- your software developers will appreciate your process
Services for Medical Software Processes at Method Park
- Definition of development processes in your context
- Maturity analysis of your development process
- User training on the development process
The right composition for your project
| Regulations | Norms | Process Models |
|---|---|---|
| MDD/MDR | 13485 | Scrum |
| FDA | 62304 | SAFe® |
| MDSAP | 14971 | TIR45 |
| HIPAA | 62366 | |
| GDPR | 60601-1 | |
| 82304 |
Questions?
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