Mediteq has experience in demanding and complex areas, and can help you to move forward in the work of risk management, clinical data, biological evaluation, and safety monitoring.
Do you need more energy and structure in your risk work?
Is risk management theoretical and abstract to you? Is it difficult for the risk team to see the completeness and end of the risk management work? Mediteq can help to create structure and plans for the risk management work including facilitating risk analysis sessions, writing complete documentation and conclusions together with the risk team.
We offer a service that can take you from understanding the requirements
to a complete risk management file according to ISO 14971.
- Training and materials
- Tools and process implementation
- Risk analysis in iterations
- Report and conclusions
Risk management work is cross-functional team work and it is important that there are available resources in your organization. Mediteq can help you do the job – but your organization have the knowledge and information about the product and its use. After implementation, you will have a definded risk process with associated risk documentation for your product, as well as knowledge to continue forward on your own or with Mediteq.
The requirements for demonstrating clinical data to comply 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 for continuously generating, collecting, assessing, and analyzing clinical data for a product to demonstrate the product’s safety and performance when used as intended by the manufacturer.
Mediteq can assist with all or parts of the work to comply with the regulatory requirements regarding clinical data. This also includes evidence strategy, clinical development plan, and post-market follow-up documentation. If a clinical trial is to be conducted, Mediteq can also assist you with planning, application, and report writing.
During development and use of a medical device, it is important to keep track of biocompatibility data. Knowledge about different materials are continously gained. With a risk based approach, Mediteq can assist in planning, analyzing, and writing the report for biological evaluation according to today’s regulatory requirements.
As a manufacturer of medical devices, you must have a process for safety monitoring of serious incidents and corrective safety measures, as well as for communication with authorities, notified bodies, and other stakeholders. Mediteq assists with reporting, investigation, and communication of relevant events and activities according to applicable regulations and participates in the manufacturer’s own processes for safety monitoring and communication.