Client: Venture-backed startup in the Physiotherapy Rehab space
Challenge
The client needed to evolve and enhance their Standard Operation Procedures (SOPs) for medical device software development, as well their Design History File (DHF) for software releases, in preparation for an ISO 13485 Certification Audit.
BlueBridge Technologies (BBT) was engaged with a short runway to the Audit. The challenge was compounded by the fact that there had been significant changes of personnel over the history of the product, and software development was being conducted by a third-party Software Development Supplier.
Approach
The BBT team conducted rapid discovery of the SOPs, DHF and related evidence, and proposed an aggressive enhancement plan.
The BBT team collaborated closely with the Engineers at the Software Development Supplier to align on updates to software SOPs that were pragmatic and workable, whilst also being compliant to IEC 62304, ISO 13485 & related standards. The BBT team authored updates to a significant portion of the DHF, in close collaboration with the Software Development Supplier.
The BBT team collaborated closely with the C-suite (of the client and their Software Development Supplier) throughout.
Outcome
The ISO 13485 Certification Audit was passed successfully, with very positive feedback from the External Auditor on the quality of the SOPs & DHF.
