Requirement engineering and development processes

Requirement engineering and design processes during the development of innovative medical products have become more complex than ever before, requiring a transparent development strategy and clear technical as well as procedural interfaces between all involved disciplines.

OPTANA has long-lasting, vast experience in the development of highly complex, demanding medical devices for critical applications like ophthalmology, cardiology, neuro-oncology and pharmaceutical applications. We understand the related technologies and design processes and are able to help your team in their requirement engineering or design process.

Software lifecycle processes (IEC 62304)

For medical devices, the IEC 62304 defines the processes necessary to develop software with a minor, moderate or major level of concern. Due to the increased complexity and functionality of software contained in medical devices, the quality, safety and reliability of software are highly dependant on the software development and change management process.

OPTANA implements software development processes to comply with the applicable IEC 62304 and US guidelines dealing with software for medical devices.

Usability processes (IEC 62366)

Usability engineering according to IEC 62366 actually attracts the highest attention in terms of medical device approvals. Usually, usability engineering is the central task of system engineering and represents a highly interdisciplinary activity between physicians, application developers, safety engineers and system architects!

As medical devices and the related applications get more and more complex and demanding management of safe, intuitive usage and highest usability has become a central topic in the device design.

OPTANA developed a clear usability engineering approach fulfilling the legal requirements of IEC 62366 and in fact, will lead to safer, more user-friendly human-machine interfaces.

Design transfer processes require a well documented and thorough description of the device assembly, testing and implemented traceability measures in respective Device Master Records. Furthermore, the applied production processes need to be developed and qualified during Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualifications (PQ).