Sotera Wireless Inc.
Premise
Sotera Wireless, Inc. is a San Diego based company dedicated to developing a new generation of early detection surveillance monitoring systems.Their flagship product, the ViSi Mobile, enhances patient safety by detecting early signs of deterioration in nearly any care setting. It enables early intervention and rapid response while allowing patients to maintain their freedom of movement. The Sotera team reached out to Rook Quality Systems (RookQS) for assistance in preparing for their upcoming 510K submission, focusing on Sotera’s compliance with the FDA’s cybersecurity guidance. The company had completed a 510K submission back in 2018 but cybersecurity requirements were much less stringent than they are currently. With the FDA cybersecurity guidance constantly evolving, the Sotera team needed assistance from RookQS to understand the current guidelines and with gathering all necessary software documentation.
Scope of Work
Sotera Wireless, Inc. had the foresight to contact RookQS in efforts of understanding how to properly comply with the FDA Cybersecurity Guidance for their upcoming 510K submission. The RookQS team recognized the need for a gap analysis to be conducted on both the process and the record deliverables in efforts of identifying any gaps in current processes and determining areas that need improvement. In addition, the Sotera team requested input on updating their current cybersecurity procedures in order to meet FDA guidelines.
- Determine whether a new SOP needs to be introduced to Trust Cyber QMS
- 510K documentation deliverables shall include:
- Software Cybersecurity Management Plan
- Software Cybersecurity Testing Plan and Protocol
- Software Cybersecurity Report
- Threat Modeling and Analysis
- Cybersecurity Risk Assessment
- Software Bills of Materials
- Review Labeling Information
- Update SRS/Traceability Matrix/Labeling if necessary
- Determine the scope and timeline of the necessary testing to be performed.
Engagement
The RookQS worked closely with the Sotera project management team in efforts of coordinating project needs with their quality, engineering, and management teams. Specifically, the RookQS team collaborated with the various teams in order to adequately define the project Gantt and work model.
Next, the RookQS led the proposal of remediations to the gaps identified during the gap analysis and in efforts of optimizing the project Gantt chart. The RookQS team explained to the Sotera team the issues that can arise with the found gaps and how such gaps can be successfully addressed. It was also important for the RookQS team to establish a realistic project timeline based on the proposed remediations.
Once the proposed recommendations were agreed upon, the RookQS team worked tightly with the Sotera team in order to implement these changes. Process enhancement was an area that was specifically focused on. The RookQS team assisted with updating procedure / work instructions and then conducted dry runs with members of the team to make sure that all technical information can be conveyed accurately and timely. Another area of remediation was the need for consolidation and complying of all technical records from software source systems. The RookQS team worked alongside the technical team in order to gather all necessary technical documents. These technical records were then put into a Section 16 software documentation of a 510K submission.
Outcome
The RookQS team worked efficiently with the Sotera team, completing all deliverables in a timely manner. The gap analysis was conducted promptly in two weeks. The remediation efforts were proposed to the Sotera team within one week and then executed and completed within three weeks. Thanks to RookQS’ help, all software documentation was properly gathered within the intended timeframe.