Medical software manufacturers likely find themselves developing and changing their software much more rapidly than their medical hardware counterparts. For software development, there is typically less prototype development and fewer manufacturing or supplier constraints. Still, there are more frequent future revisions to enhance features, maintain compatibility, or remove software bugs. More simply, traditional medical devices go through fewer revisions throughout the product lifecycle, and software is built with the intention to iterate rapidly.
FDA Regulations
All medical products must follow the FDA regulations and ISO Standards for design control. Design control processes are necessary to ensure manufacturers are creating the products they intend to create. To help software manufacturers navigate design control, DeviceLab has the tools to implement a successful medical development process.
The DeviceLab medical software development process is led and implemented by your assigned DeviceLab project manager. The project manager will act as the main point of contact for all things related to the medical software project. In addition, the project manager will schedule all FDA 21 CFR 820 and ISO 13485 required design reviews and all informal progress meetings.
Six Critical Tracks to Get Started on Developing Medical Software
To get started on developing medical software, the project manager will design out six critical tracks:
- Intellectual Property Support Track: manages patents and ensure the product will be protected
- Product Design Track: technology development and engineering work
- Risk Management and Design Control Track: ensure the product meets safety requirements and all documentation is appropriate
- Manufacturing Track: manages to upscale manufacturing and suppliers
- Human Factors and Usability Track: assess the products from a users perspective
- Compliance and Regulatory Support Track: maintains FDA and EU filing, ensures the product complies will all regulatory requirements.
Each of these tracks will be critical in assessing the initial medical software product and all future iterations of the software. Initially, the software development process will follow the same structure as a traditional medical device.
Once the software is initially released, the development team will likely begin preparing for a revision or update to the software. This is where development for medical software can become unmanageable. As software becomes more complex and interacts with other products, the software will have more scheduled iterations, and developers will need support to ensure they are working within the regulated processes. Manufacturers are required by FDA regulations to maintain design controls.
Contact DeviceLab Today
DeviceLab is here to help ensure medical software products are iterating using the regulated design control processes. To manage software revisions and future developments, DeviceLab employs the Agile method. DeviceLab will utilize sprints and focus on prioritizing deliverables to bring your software revisions to market as soon and safely as possible. DesignLab will develop detailed requirements to maintain risk and accelerate product development. Contact DeviceLab today to learn more about the different ways DeviceLab can help with your medical software development.
