Key Roles and Required Skills

1. Front-End Developer (React): Required deep expertise in React and a strong understanding of migrating legacy systems.
2. Quality Assurance Engineer: Knowledge of ISO 13485 compliance for software development was critical to ensure that testing met regulatory standards.
3. Project Manager with ISO 13485 Experience: Needed to oversee the entire process, coordinate documentation for regulatory review, and manage timelines.
4. UI/UX Designer with Healthcare Experience: Tasked with optimizing user interfaces for medical professionals, ensuring accessibility and usability.

Our Approach

Requirement Analysis and Discovery Phase:

• We began by meeting extensively with the client’s product management and compliance teams to understand their pain points and priorities for the new front end. During these meetings, we documented not only technical needs but also regulatory requirements, usability challenges, and end-user expectations.
• This discovery phase allowed us to translate the client’s broad goals into a clear, actionable roadmap, aligning with ISO 13485 standards.

Targeted Candidate Search and Selection:

• We crafted detailed job descriptions emphasizing not only technical expertise in PHP and React but also specific experience with ISO 13485-compliant software development. We used a rigorous screening process to identify candidates with both technical and regulatory experience.
• Through our networks and targeted outreach, we connected with candidates experienced in healthcare and life sciences software who understood the nuances of compliance-driven development. Our ability to screen for these unique attributes ensured we found candidates who could handle the dual demands of technical migration and regulatory adherence.

Building a Collaborative Development Team:

• We formed a cross-functional team consisting of developers, quality assurance engineers, a project manager, and a UI/UX designer. Each team member brought both technical skills and experience with ISO 13485 requirements.
• To ensure the team stayed aligned with compliance standards, the project manager conducted regular check-ins and collaborated with the client’s regulatory team to ensure all documentation met ISO standards.

Executing the Migration:

• Code Migration: The developers rewrote the front-end codebase in React, maintaining a strong focus on scalability, readability, and maintainability. Throughout this process, they documented each step in alignment with ISO 13485 standards to create a traceable path from the legacy PHP system to the new React-based front end.
• ‍Quality Assurance: The QA engineers conducted extensive testing, including unit tests, integration tests, and user acceptance tests, to verify that all features functioned correctly. The tests were documented to meet regulatory requirements, ensuring that the software could be validated and audited as needed.
• ‍Usability Testing and Feedback: The UI/UX designer collaborated closely with end-users (healthcare professionals) to refine the interface, conducting usability testing to ensure that the new design was intuitive and efficient for clinicians.

Compliance Documentation and Handoff:

• At the project’s conclusion, we provided the client with a complete set of documentation, from design specs to testing logs, which met ISO 13485 standards. This documentation was essential for regulatory reviews and audits, confirming that the software adhered to compliance standards for medical devices.