Summary
What do you do? Describe your company.
Imspex Diagnostics Limited is an SME organization with rich experience in researching and developing cutting-edge analytical solutions that act as early warning systems for use in healthcare, in the environment and in industrial applications. Imspex’s proprietary gas chromatography-ion mobility spectrometry (GC-IMS) technology has shown that it is ideally suited to detect and diagnose a number of different medical conditions by analyzing breath samples.
Imspex Medical is the division of Imspex Diagnostics Limited that is tasked with streamlining this technology and taking it to market for use as a medical device that can detect and diagnose a range of health and medical conditions.
Challenge
What was your problem, and what challenges prevented you from easily solving the problem?
As a small company just entering the medical devices market, Imspex did not have the in-house expertise to identify or create the necessary QMS that would meet all the requirements of the ISO 13485 standard and comply with European IVD directive and regulation.
How did you find out about our solution? Did you consider other providers? What criteria did you use to select BPA and Microsoft?
BPA was recommended by a network of consultants and local life-science organizations in Wales. Imspex opted for BPA on account of the flexibility that it offered for a small but growing company that would need a QMS that could be easily expanded.”
What was the solution? How did it address your challenges?
BPA Quality and its associated Flows helped Imspex establish an ISO 13485-compliant QMS that was integrated into the existing IT infrastructure at Imspex. This was completed successfully within the tight timeframe of nine months from signing the contract to completing the successful certification audit.
Strategy
How did you implement the solution? How long did it take? What new challenges did the implementation create?
Imspex selected the basic 21h package for installation and training and online configuration sessions took place once a week or less. The training was efficient and economical, and the full implementation took approximately five months. The upload of all documentation and training of users was achieved in a further three months.
The challenges encountered by staff related mainly to the document module, particularly when having to work through large numbers of compliance documents when these were first uploaded onto the system. A future challenge will be to train the next power user. This will be made easier by using all the configuration sessions that were recorded from this initial round of implementation.
Results
What results did you gain from BPA Solutions – both anecdotally and measurably?
The key result from this partnership with BPA is that Imspex successfully achieved ISO 13485 certification in the span of nine months from signing the contract to being audited in September.
