Small medical device companies struggle to ensure that their systems and processes, including labelling, are validated and compliant with stringent regulatory standards aimed at ensuring traceability of medical devices.
It is a major undertaking and can be a costly process.
One key area they find difficult is keeping labels up to date and ensuring they are set up in a correct and compliant manner, which involves having all the relevant symbols in place to comply with the EU MDR or FDA regulations – whichever is most appropriate – so the business can change the designs of the label templates themselves.
Small medical device manufacturers clearly have a lot on their plate in terms of validation and compliance. So how can they go about finding a solution to the challenges they face?
The emergence of validation-ready cloud labelling solutions represents a positive way forward. Carrying out labelling in the cloud drives scalability and productivity for small medical device manufacturers, as well as supporting enhanced efficiencies.
The latest cloud labelling solutions can support cloud to cloud integration. They can also have validation documentation to ease the strain on IT because much of the validation process, including installation qualification, can be handled with minimal involvement from the medical device business’ IT staff.
Additionally, since the labelling system is hosted in the cloud, companies can rely on vendor supplied documentation when it comes to installation and hardware qualification. The manufacturer itself is left with a much lighter burden and a streamlined path to a validated system and process. This is appealing to life sciences companies who appreciate a more relaxed release schedule which comes from updating the software once a year rather than multiple times.
The manufacturer would of course need to work closely alongside the vendor and review and accept the documentation, but the vendor is able to do much of the work for them – providing not only the system and solution but also the full validation pack. In these scenarios, vendors sometimes claim that their labelling solution is ‘qualified’, meaning they set up a lot of documentation and testing when they set up ‘the blank’ labelling system.
The small medical device manufacturer then only has to validate its usage of that software. They can begin from a high level, which makes the critical process of achieving validation and compliance much easier and more seamless. The benefit of this is that because the device is already qualified, it really speeds the process along and is much faster for the manufacturer.
Such solutions can, in certain scenarios, be used out of the box, but the best providers can also help validate commercially available software and provide a validation acceleration pack or documentation for it, as well as providing consultancy and advice around validation where it is needed, tailored to the business’s specific needs.
As such, it is likely that having a cloud-based labelling system will remain especially key to achieving compliance, since the technology is future-proof. Medical device manufacturers can be confident that vendors will be continuously updating it, enabling them to address the fast-changing upcoming new regulations and cope with whatever comes their way. Moreover, under the current pandemic conditions, where there are restrictions on people meeting face-to-face, it is a great solution to keep labelling operations moving forward.
If you would like to know more about the NiceLabel Label Compliance system, please do get in touch.