Provision of objective evidence, that specified requirements have been fulfilled. The product does it right.
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- Market Access for Artificial Intelligence in MedicineHow does current regulation for market access fit with artificial intelligence in medicine? Find out more by a practical example.
- Technical Documentation: See the Opportunities, not the Challenges!The technical documentation of medical devices in the EU must be revised. We tell you what to keep an eye on and how to make it a success!
- Cyber Security Threats in HealthcareCyber security threats affect medical device safety and patient protection. Learn here how to perform best regarding risk management.
- How to Perform Clinical Evaluation of Medical SoftwareManufacturers must do a clinical evaluation of a medical device before they can market it in Europe. Find out what you need to keep in mind.
- Transition Period of the EU MDR: What Dates Manufacturers Need to KnowThe new EU MDR is complex and challenges the manufacturers. We explain what you need to pay attention to in the transition period.