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Digital health & cybersecurity
Our dedicated team of experts are here to support your medical software development and data management with respect to regulatory planning and quality assurance.
Digital health and cybersecurity
Digital health services
The global digital transformation of healthcare has resulted in an explosion of medical device software (MDSW), whether functioning as a medical device (SaMD) or as part of a device (SiMD), possibly involving AI, IoT, mobile apps, or telemedicine. Also, cloud-based computing and the use of software as a service (SaaS) have increased considerably in the medical device sector. At the same time, regulatory expectations for cybersecurity, control of AI, and health data protection continues to get more stringent. We help medical device developers to tackle these challenges. Our digital health regulatory experts understand modern digital health solutions; we understand the development process and can support you to foresee risks associated with the digital medical landscape and adhering to local and global data protection and regulations.
Cybersecurity services
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 (QMS) that include cybersecurity from the start. We can support in creating compliant medical device security documentation such as:
- Threat modeling and cybersecurity risk assessment and its integration with the safety risk assessment
- Architecture
- Verification
Regulatory and quality assurance services
- Regulatory strategy planning in line with EU, FDA, and other regulations to ensure your product meets the requirements
- Technical documentation creation for your medical device
- Building an Electronic Quality Management System (eQMS) such as scilife.io or expanding Atlassian for QMS use
Get in touch with us
Explore our quality and regulatory services
Regulatory strategy
We help you develop an efficient regulatory strategy to meet applicable regulations, mitigate risks, and accelerate time-to-market for your medical device.
Market registrations
Let our team of experts support market registrations of your medical devices in the EU, US and other markets.
Digital health and cybersecurity
Dedicated regulatory and quality experts to help you streamline your medical software development and ensure that you adhere to local and global regulations.
Technical documentation
Expert support in planning, preparing and updating your technical documentation to help you ensure compliance with applicable regulations.
Clinical evaluation
Proven expertise in planning and conducting a thorough clinical evaluation that supports the regulatory approval of your medical device.
Performance evaluation
Dedicated experts in planning and conducting a thorough performance evaluation that supports the regulatory approval of your IVD medical device.
Biological evaluation
We support you in planning and conducting a thorough biological evaluation of your medical device that is compliant with ISO 10993-1.
Risk management
Medical device risk management services for setting up and maintaining your risk management process and helping you prepare your documentation.
Usability engineering
Support for your usability engineering activities, from creating a process to preparing a usability engineering file for your medical device.
Due diligence
Quality and regulatory experts ready to support your due diligence projects with comprehensive appraisals of medical device businesses.
Person Responsible for Regulatory Compliance (PRRC)
Our experts can support you in understanding the full range of PRRC responsibilities.
Quality management system services
QMS services for medical device manufacturers to help you design, implement and manage your QMS to support your organization's needs.
US FDA QMSR
Expert guidance on the US FDA's QMSR and other US regulatory requirements to help medical device manufacturers successfully enter the US market.
Auditing services
Improve your quality management system with our internal auditing services for medical device manufacturers.
Post market surveillance
Post market surveillance services to help you systematically gather and analyze data on the quality, performance, and safety of your medical device.
Our customer-centric approach means that our client’s needs guide our focus to create impactful results.
We prioritize transparency, dependability, and delivering high-quality results.
We deliver agile, tailored solutions through deep expertise and a commitment to excellence.