Address your Medical Device & IVD Cyber attacks
Contact our experts to maintain your Agile development environment while fulfilling regulatory requirements induced by the cybersecurity guidance.
From planning through development to the release of your MD or IVD
The software industry faces important challenges with new MDR and IVDR. Cyber-attacks are not just a potential threat, they are a reality, and even more in the healthcare sector where software’s are dealing with human data.
You may have wondered which fundamental regulatory activities to undertake to gain market access for medical device software.
From development, planning stages up to release of your medical device, Medidee can help you along the way to:
- Understand how cybersecurity is linked with regulatory requirements
- Understand your scope of responsibility as manufacturer
- Determine a verification and validation plan for your AI based software
- Target the specific aspects of GDPR apply for your medical device software
- And much more!
By establishing a system approach, and by structuring requirements, your team will be empowered to master the inventory of constraints applicable to your software. Want to be compliant with cybersecurity requirements for your medical device and IVDD? Contact us now!
Interested in knowing more about MedTech cybersecurity requirements?
Download our free ebook to get to know key resources for both knowledge and application of fundamental security concepts to the lifecycle of medical and IVD devices.