Medical Device Mobile Software Application Clearance and Compliance
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Intertech Engineering Associates, Inc. was asked to assist in a 501(k) re-submission for a client’s medical device mobile software application after their initial submission had been rejected by the FDA. The application was to be used for fetal monitoring on the iPhone and iPad platforms using a Visual Studio Team System development environment. Intertech’s goals were to get the client design and development processes and documentation compliant with FDA regulations before resubmitting their 510(k). The timeline was aggressive and resources at the client’s organization were limited.
Several regulatory standards were in effect including ISO 14971, 21 CFR 820-Quality System and Regulations and the FDA’s General Principles of Software Validation Guidance and the FDA’s Submission guidance for medical devices containing software. Intertech started by conducting product and process audits to determine areas of improvement. In addition, the quality system was also reviewed to suggest improvements that would be applicable to the regulatory submission. As the project progressed, design documents, verification and validation and risk analysis reviews were performed and changes and improvements were suggested to achieve maintainability and quality compliance. These included lean design control quality system process recommendations for quality and design control compliance.
The effect of this complex design and software review process under tight time constraints was that Intertech delivered a software documentation submission list, streamlined design control quality system processes, quality system ‘friendly’ audit reviews with recommendations and software development verification and validation review summaries with recommendations. This resulted in a successful clearance upon resubmission of an FDA compliant mobile software application. Apple often used this device as an example of a successful medical application on the iPhone and iPad platforms.
Mobile Software Application Clearance and Compliance Project Highlights
- Project Description
- A startup company had developed a mobile device application and submitted their pre-market notification to the FDA. The FDA quickly rejected the submission for a variety of reasons. The Client needed to get their design and development processes and documentation compliant with FDA regulations before resubmitting their 510(k).Resources were scarce; time was of the essence. Intertech provided advice and some process documents to assist with device validation and compliant design control processes to support and FDA resubmission.
- Project Outcome
- Product achieved 510(k) clearance easily upon resubmission and was one of the first successful examples of releasing an FDA compliant mobile software application. In fact, the device was often shown by Apple as an example of a medical application on the iPhone and iPad platforms. Product and process changes were made to facilitate efficiency and compliance. Using Intertech as a consultant and coach achieved the goals for relatively low cost.
- Type of Project
- Process and product compliance
- Product FDA clearance
- Project Rescue
- Tools Used
- Operating System
- iPhone iOS
- RIM Blackberry OS
- Microsoft Pocket PC (Windows Mobile Classic)
- Development Environment
- Visual Studio Team System
- Operating System
- Intertech provided product and process audits, proposed solutions to put quality system and development processes into compliance.
- Intertech provided software submission deliverable list and software technical content for FDA 510(k) submission.
- Intertech recommended lean design control quality system process recommendations for quality and design control compliance.
- Intertech performed design document, V&V and risk analysis reviews and suggested changes and improvements to achieve maintainability and quality compliance.
- Intertech worked with client and FDA to produce a plan for configuration management, validation, and regulatory submission for devices on mobile platforms that suffer from frequent updates outside the medical device manufacturer’s control.
- Software documentation submission list
- Streamlined Design Control Quality System Processes
- Quality system ‘friendly’ audit reviews and recommendations
- Software development and V&V review summaries and recommendations
- Services Used
- Quality (FDA) compliance engineering
- Risk (safety analysis)
- Verification and Validation planning, test development and execution
- Submission consultation
- Quality System Compliance consult
- Processes Used
- Systems Engineering
- Software Quality Engineering
- Standards / Regulatory Compliance
- ISO 14971
FDA – General Principles of Software Validation Guidance
- 21 CFR 820 - Quality System Regulations
- FDA- Submission guidance for medical devices containing software
- ISO 14971
- Delivery/Turnaround Time
- 3 months
- Product Type
- Remote Fetal Monitor on App Platform