A new version of the IEC 61010 standard has been released. After a transition period, market instruments must comply with the latest requirements. The client needs to determine if their device meets the new standard or requires updates.
The process began with a delta analysis to identify differences between the old and new IEC 61010 versions. Next, we reviewed the client’s documents, including the technical file and verification tests. A GAP analysis then pinpointed discrepancies with the new standard. Solutions for these gaps were devised, with the client addressing some and BIT implementing others on their behalf.
After making the necessary updates, the instrument now meets the new IEC 61010 standards, allowing the customer to keep their device on the market for several more years.
The instrument was launched before the IEC 62304 standard for medical device software lifecycle processes was established. After a transition period, instruments on the market must comply with current standards, including any updates or new requirements. The client now needs guidance on how to align with this standard.
The initial step involved reviewing the client’s documents related to the instrument’s software, including the technical file and verification tests. Next, the IEC 62304 standard was analyzed to identify all necessary requirements. A GAP analysis followed, pinpointing discrepancies with the standard’s requirements. BIT then determined the most efficient methods to address these gaps, as standards often allow multiple compliance strategies. Subsequently, BIT conducted the required tests, updated the risk analysis in collaboration with the client, and created any missing documentation.
Following the technical file update, the instrument achieved compliance with the IEC 62304 standard, allowing the customer to continue marketing the device successfully.
A global leader in aesthetic surgery sought BIT’s expertise to update and redesign a widely-used tumescent pump, aiming to expand its application range.
This task was made even more challenging by the need for enhanced usability, a significant obstacle for our client. Fortunately, BIT was able to bridge this gap with its development expertise, regulatory knowledge, and a lean approach to task execution, including both formative and summative evaluations. This process encompassed everything from initial planning to implementation during the development phase for formative aspects, and culminated in final testing of the prototypes for summative evaluation at the development’s conclusion.
BIT successfully met the usability requirements, ultimately facilitating a smooth approval process for the client.
