Medical Device Security
What is it about?
During the last decades, the medical device market has made enormous progress moving from manual devices, to highly advanced systems, and integrated with the systems of clinics and hospitals.
This advancement also brings with it new challenges, as these devices are able to have access to highly confidential information related to patient data.
This requires the adoption and the conformity to regulations.
You should be careful..
Failure to adequately prepare for these medical device regulatory compliance requirements could result in fines, penalties, and loss of market access, which can directly and negatively impact your business.
Based on the jurisdiction where you are operating, or willing to, you will have to comply with the requirements of market and local regulations, and probably being subjects to audit reports and controls.
The efforts required to implement such regulations shouldn't be underestimated: failure to adequately prepare them could result in fines, penalties and loss of market.
Adopting these requirements can also be the opportunity to increase efficiency, allowing the company to focus where it most matters to their stakeholders while reducing time spent on non-value-added activities.
Where to start?
Proper planning, preparation, and implementation of the necessary changes can lead to market share advantages, improvements to operational and quality process efficiencies and a positive impact in front of customers and stakeholders.
How to start?
Based on the market your company is active, there could be different regulation to which you might be subject: FDA, HIPAA, ISO 13485, ISO 14971, ISO 29151, ISO 80001 or ISO 81001.
We could help you to run an initial assessment and to perform a gap analysis to perform the needed concrete steps for the compliance.
Let us help you!
Let's understand together which are your main challenges, the data that you need to keep protected, the regulations you are subject to and let us show how we can help!Check our services