THE PROBLEM
The last 10 years has seen a significant leap forward in terms of the
availability of computing power and their integration into medical
devices. This has allowed for significant improvements in patient care,
with the computer processing power of typical implantable cardiac rhythm
management systems now exceeding that of the Apollo moon missions.
This trend is expected to accelerate, both because of the performance
and safety improvements software offers to individual medical devices,
but also because of the integrated, data-hungry nature of the ‘AI
promise’ to solve bigger healthcare questions.
What has not kept pace with this exponential growth is the specialist
skills required to deliver it in a safe and effective way and in line
with regulatory standards. As a consequence, many MedTech start-up fail
to fully understand and implement these development standards, make poor
platform and development decisions and risk significant regulatory
delays and rework costs.
THE SOLUTION
We can provide you with a full range of IEC62304 compliance support,
starting from SDLC development and business gaps identification. We will
support your software development team at all project stages, from
beginning to production.
Here’s what we can do your business:
- SDLC development: either create a new IEC62304-compliant SDLC or make improvements to an existing one
- Train relevant personnel on all aspects of IEC62304 and SDLC
- Provide IEC62304 documentation templates
- Helping with achieving ISO13485 and IEC60601 certification (software-related parts)
- Advising on necessary V&V process
- Provide an ongoing support at any stages of your project
OUR EXPERTISE
We at Inmarsys have first-hand in-depth expertise in creating software
for Medical Industry under IEC62304-compliant processes. The projects we
participated on were always driven to certification either by FDA
(under 510(k)) , BSI or both.
For more information please Contact us and we’ll be happy to help you with your software project.
