Services to provide you with assistance in the development of software

The Quality assurance of software spans over multiple areas, all of which has an impact on the function of the final product. We have noticed that there is a great uncertainty among medical device manufacturers regarding software and its documentation and validation.

We can offer you services within:

• Life cycle management of software development
• Validation of software, both for the manufacturing process and for the product

Is your software a medical device?

According to the revised MDD from March 2010; software used for support in decisions regarding diagnosis, treatment or monitoring of patients are now considered to be medical devices and must be CE-marked. At Symbioteq, we have extensive experience with CE-marking of medical devices and we have helped several large suppliers of software to the healthcare industry with issues regarding CE-marking.

We can help you to:

• Review you products and help you determine if any of the products should be classified as medical devices
• For products that have been identified as medical devices, we can provide you with a briefing of applicable requirements and a suggestion on how to work to meet these requirements
• Establish the necessary technical documentation