Digital health, data and cybersecurity

Digital Health Services

The global digital transformation of healthcare brings with increase of software as a medical device or as part of a device, possibly involving AI, IoT, mobile apps, or telemedicine. At the same time, there are growing regulatory requirements for medical software and health data management, along with information security concerns. We help medical device developers to tackle these challenges.

Our in-house digital regulatory experts and medical software developers understand digital health solutions; we understand the development process and foresee risks associated with the digital medical landscape while adhering to local and global data protection and regulations.

Cybersecurity

Cybersecurity in medical devices is critical given the increasing integration of software and connectivity in healthcare technology. Many regulatory agencies have therefore focused specifically on this area with outlined regulatory requirements on cybersecurity and data privacy.

We can support building Quality Management Systems that include cybersecurity considerations:

Threat identification
Risk assessment
Secure design and development
Authentication and access control
Data protection
Updates and patch management
Network security
Incident response planning

Regulatory and Quality Assurance services

Regulatory planning in line with EU, FDA, or any other regulation to ensure your product meets all the requirements
Creating software development environments that can be connected to your Quality Management System (QMS)
Building an Electronic Quality Management System (eQMS) such as scilife.io
Integration of Jira/Confluence workflows into your electronic QMS (eQMS)

Development services

Medical software development and proof of concept with our in-house software developers
Data management services to handle sensitive information securely and in compliance with GDPR
Technical documentation creation for your medical device