Medical software development and cybersecurity

Medical software includes both so-called stand-alone medical device software and software embedded in a medical device. Related regulation can appear complex and hiring experienced developers may become a challenge. For companies developing medical software, we offer outsourcing and other services for product development, and regulatory planning and management.

Throughout the software development lifecycle, collaboration between interdisciplinary teams, including software engineers, quality assurance professionals, regulatory experts, and clinicians, is essential to ensure that the software meets the necessary requirements and standards for medical devices.

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.

Your Quality Management System for medical devices needs to include at least the following 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

Medical applications compliant with regulations

Our project managers are responsible for following the international standards and other regulations specifying life cycle requirements for the development of medical software. We have dedicated in-house teams who work with quality management systems (QMS), regulatory affairs and data management. This allows effective production cycle, as ensuring compliance with MDR and other applicable standards and regulations is among our core capabilities.

Regulatory Planning

We have expertise in regulatory planning for different markets, including the EU, FDA, and other regions, ensuring your products meet all the requirements. Our team can assist you in defining and documenting software requirements, ensuring your systems fulfill usability requirements, are compliant, and meet medical electrical standards.

Outsourcing medical software development

We have a solid experience in the product development process for creating medical software. Our software developers and project managers know how to create medical apps and other software solutions that are not only functional, but also compliant with the regulations and standards.

In addition to software development, we provide outsourced project managers and head of development as service. We also create proofs of concepts. We assist you in charting, introducing and configuring the required development tools, and ensure project progress according to plan and on schedule.

Product Development Health Check

Product development health check allows you to ensure that the project is appropriate and fulfils requirements and you have sufficient resources and the right tools and methods for completing your project successfully.

Product development health check is a light, audit-like preliminary evaluation that involves examining the current state of your product development in relation to the requirements set by the medical device software – Software life-cycle processes standard (EN 62304:2006). The service is highly beneficial, for instance, when a software company that has already established its presence expands its operations to medical software.

Detailed plan for executing medical software development project

After thoroughly familiarising with your project and reviewing the development documentation, we will provide a list of observations and draw up a plan of measures and a schedule for correcting any deviations and failings that may have been detected.

Regulatory plans

Our experienced professionals help medical device manufacturers develop regulatory plans that support their entire product lifecycle.

Technical documentation

All medical devices must have documentation available to support its compliance to applicable regulations. Aurevia supports you in planning and developing your technical documentation.

Electrical Safety IEC 60601

IEC 60601-1 is the basic international safety standard for medical electrical devices and systems.

Biological Safety ISO 10993

The international standard for the biological safety evaluation process and preparing biological evaluation documentation for medical device manufacturers.

IVDR compliance for in-house developed tests

Laboratories developing IVDs in-house must maintain technical documentation and Quality Management Systems to comply with the IVDR and national law.

IVD performance evaluation

In vitro diagnostic medical device (IVD) regulations are set in the EU In Vitro Diagnostics Regulation (IVDR).

Qualification and classification of medical devices

Our team’s versatile experience and the available tools help in bringing clarity to the most challenging cases.

Medical software

Let our experts help you understand and adhere to medical device software regulations throughout the entire lifecycle.

Risk management ISO 14971

We can help you setup and implement a risk management system and prepare risk management documentation.

QAdvis and Scandinavian CRO join Aurevia to strengthen clinical research and regulatory expertise

Scandinavian CRO (SCRO) and QAdvis will now operate under the name of Aurevia.

Meet us at ESCMID 2025 in Vienna

We will be at the ESCMID 11-15 April 2025 in Vienna, Austria.

Aurevia appoints Jonna Pelanti as the new Head of EQA business area

We are delighted to announce the appointment of the new Head of the EQA business area Jonna Pelanti.

Meet us at BioMedica in Dublin

Meet us at the BioMedica exhibition at booth A18!

Aurevia appoints Ulrika Hammarström as the new Head of CRO business area

We are delighted to announce the appointment of the new Head of the CRO business area Ulrika Hammarström.