Mediteq can help you to determine if your app or eHealth solution is a medical device that requires CE marking, or if showing reliablity and high quality is sufficient. We can also support your launch in the USA and the need to meet FDA requirements. Together, we develop a plan for how to achieve this, where we provide the requirements and standards that need to be met, and you provide knowledge about your software product, its intended use, and future markets.

We try to find simple and iterative ways to introduce the routines and methods required to meet current regulatory requirements or create high-quality software, no more, no less! The extent of traceability and documentation from the development process and lifecycle depends on the software’s regulatory class and security class. Initially, we investigate this to set the right level of requirements and work for you.

We have previous experience in technical software development from both embedded and stand-alone software now referred to as SaMD and SiMD, i.e., Software as Medical Device and Software in Medical Device.

We have worked with:

• several electronic health record systems
• apps for diabetes and insulin management
• software for analyzing lab tests, including various types of cancer markers
• dental software for image analysis and implant planning

Mediteq keeps up to date and has been participating for many years in the standardization of software in TK62, which writes the IEC 62304 and IEC 82304 series. For data and information management, we participate in TK334 for Health Care Informatics. Nowadays we also participate in standardization of AI in medical technology.

Since medical device software (MDSW) manage data of various kinds, we have knowledge in data management and its legislation, including GDPR, data management in clinical trials and proposed EU regulation EHDS (European Health Data Space).

The following services can be focused on medical software:

• Regulatory analysis and regulatory strategy
• Start CE marking
• Training
• Advisory and operational services
• Review of technical documentation
• Internal audit