CASE STUDY
Compliance to IEC62304 achieved within 4 weeks
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CASE STUDY
Compliance to IEC62304 achieved within 4 weeks
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Full IEC62304 compliance
through tailored 4 week action plan
The start-up venture required support to help document and reach compliance to IEC62304 within a tight timeline ready for their medical device audit.
Outcome
IEC62304 Checklist: Fully evidence technical file documentation in a easy to audit format.
Design inputs: Clear guidance on how to best capture design inputs in line with their exisiting development processes.
Design outputs: Verification and validation documented with full end-to-end traceability.
Reviews: Third-party reviewers to ensure quality of code and testing.
Challenges
- Aligning with exisiting development processes
- Legacy software that had not been developed to IEC62304
- Lack of internal software regulatory experience
- Tight timeline to meet audit dates.
About this start-up venture
This start-up venture’s breakthrough technology provides rapid testing of UTI’s increasing the accuracy of infection identification to help prescribe the current treatment course. .
Location: UK
Company size: Start-up venture 10+ employees
Industry: Medical
We would highly recommend working with the ANDtr team
CTO, LLusern
Approach
Gap Analysis
Deep dive into the areas of compliance that were not met and developed a clear action plan
Workshops
Undertook working meeting with the team to quicken documentation and testing
Hands-on
Conducted code and design reviews, testing, QMS documentation handling, and oversight for compliance.
Audit support
Provided software expertise to support post audit remediations.
Potential for non-invasive microcirculation technology to save countless lives
Rapid urinary tract infection (UTI) testing can significantly improve clinical outcomes by enabling faster and more targeted treatment decisions. Traditional urine culture methods can take 24–72 hours to identify pathogens and determine antibiotic susceptibility, often leading clinicians to prescribe broad-spectrum antibiotics empirically. Rapid diagnostics shorten this timeframe by identifying the causative organism and, in some cases, resistance markers within minutes to hours. This allows clinicians to initiate appropriate therapy earlier, reducing symptom duration, preventing complications such as progression to pyelonephritis or sepsis, and minimizing unnecessary antibiotic exposure. Earlier targeted treatment also supports antimicrobial stewardship by reducing inappropriate prescribing and slowing the development of antimicrobial resistance. In settings such as primary care, emergency departments, and care homes, rapid UTI testing can additionally reduce repeat visits, hospital admissions, and overall healthcare costs while improving patient satisfaction and recovery times.
“…working with ANDtr has been seamless and productive”
Senior Director
It was fanastic to see the teamwork and speed at which we were able to partner with Llusern. The action plan provided a clear route to achieving the compliance within the timeframe. /p>
