Engineering

Our design and development process implements industry standard such as IEC 62304 – medical device software – software life cycle processes. We combine agility with regulatory compliance; our ISO-certified processes aim at delivering state-of-the-art products and solutions while following the Agile Manifesto, relying on an iterative approach that encourages:

• Interaction: dialogue between functions is facilitated and project teams are inherently multidisciplinary.
• Task  parallelization: the agile approach encourages tasks to be parallelized to constructively iterate on the solution.
• Responsiveness : SaMD development requires to respond to change swiftly and accurately, while enforcing robust version and configuration management policies.
• Customer collaboration : customers are involved in each project from day 1 and follow the project through its entire life cycle.

Beyond being your main point of contact, your Voluntis project manager ensures that your project fully meets your expectations in terms of cost, time and quality throughout design, development, validation and delivery phases. In addition to traditional software project management, Voluntis project managers are able to coordinate all activities involved in medical device manufacturing (such as human factors engineering, product risk management or clinical evaluation), together with our subject-matter experts.

Our engineering team puts safety and connectivity at the heart of our projects

• About risk management: our approach is based on ISO14971 and has been proven across multiple DTx project of moderate to high safety risks (e.g. class C per IEC 62304). Our engineering approach is based on a systematic analysis of design elements and allows to:
  • Cover all potential sources of risks, including software failure risks, cybersecurity risks or use-related risks.
  • Assess risks based on latest regulatory guidance and directives.
  • Optimize the work of subject-matter experts, such as clinicians, leveraging robust tools and processes.
• About connectivity: the architecture of our platform and solutions is open in nature. We recognize that DTx must fit within a broader healthcare IT ecosystem in order to facilitate adoption and usage by end-users. This means integrating with medical devices (e.g., drug delivery systems, sensors and digital biomarkers), third-party software (e.g. ERPs, CRMs, SFAs) and EHRs/EMRs. We design and implement strategies to connect our DTx with this diverse ecosystem while maintaining compliance with applicable design controls and data privacy regulations.