Medical Device Regulation
You are no doubt aware that the Medical Device Regulation has been published and therefore enacted. After the transition period ends, all medical software must comply with the necessary requirements. Do you know if your portals, medical applications and other software classifies as a medical device? What do you need to do if your digital solutions need to have a CE approval? What will the impact be on your organization and processes? It is important to interpret the regulation correctly so that the controls are aligned with the goals of the organization.
Statement of applicability
It is important to keep an overview of your digital health solutions and to understand which category they come under for regulatory purposes. Do you have a clear understanding about the classification status of all medical devices used in your organization? We can help you with this and provide you with a statement classifying of your different devices.
Roadmap to compliance
What are the things ‘to do’ in order to comply with the relevant legislation? Which documents are needed? Which controls need to be operationalized? Which process needs to be implemented? And what are the priorities?
We screen your organization, (software development) processes and daily operations and provide you with a roadmap that provides answers to all your questions.
It is of the utmost importance that your employees understand and support the processes and controls that are implemented. Your entire organizations need to follow these standards. We can help you during implementation but also in the operationalization phase. We enable you to become compliant and make sure you remain compliant as well.
Please contact us if you want to have more information or download our onepager.