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Risk management
Do you need additional energy in your work regarding risk analysis?
Simplify? Structure? Define? Expand the toolbox?
Make it easier to iterate? Link STED to the risk analysis?
Mediteq will assist you!
We offer a module package that will make you understand the requirements to complete a documentation regarding risks.
- Education and basis
- Demarcation
- Tools and implementation
- Analysis and report
When the work is to be carried out, it is important that there are available resources in your organisation.
Mediteq can help you do the job – but you are the one who has the knowledge and details about your product and how it is used.
After implementation, you will have a started and documented risk analysis with associated risk documentation, as well as solid knowledge on the road ahead.
Clinical evaluation
The requirements to show clinical data to demonstrate compliance with the regulatory requirements in the EU have increased for all medical devices. Clinical data is information about a product’s safety and performance that is collected during the product’s use. The clinical evaluation is a planned process to continuously generate, collect, assess and analyze clinical data for a product to prove the product’s safety and performance when used as intended by the manufacturer.
Mediteq can help with all or part of the work to meet the regulatory requirements around clinical evaluation. This includes the evidence strategy, clinical development plan and the post-market follow-up documentation. If a clinical trial is to be carried out, Mediteq can also help you with planning, application and report writing.
Biological evaluation
Both during development and when the medical device is in use in healthcare, it is important to keep an eye on its biocompatibility. More knowledge about different materials is added continuously and through a risk management perspective and Mediteq can help you plan, analyze and write the report for the biological evaluation according to today’s regulatory requirements.
Safety monitoring
The requirements to demonstrate clinical data for compliance as a manufacturer of medical devices, you must have a process for safety monitoring of serious events and corrective action and for communication with authorities, notified bodies and other stakeholders. Mediteq can help with reporting, investigation and communication of relevant events and activities according to current regulations and the manufacturer’s own processes for safety monitoring and communication.