Science News
- July, 7-2010.
- New references of harmonised standards for Medical Devices...
- June, 18-2010.
- New Guidance document on classification of medical devices...
Affiliations
Medical device & drug innovation is the best way to ensure the future of the healthcare market
The challenges that European Healthcare enterprises face in the current landscape, from research to market, are multiple.
Fostering innovation in healthcare is a particularly difficult and articulated process, due to the escalating costs and the long time frame for healthcare product development and regulatory approval.
At Eudax we teamwork with our clients, finding the most suitable solutions to develop their projects and ensuring their success. Contact our experts to discover how we can assist your company to be compliant with EU and US Medical Device Regulations.
Clinical Trial
- Clinical research brings new
- treatments to patients, e.g. new therapies (drugs), new surgical procedures (medical devices)...
- Clinical trials aim at determining
- the safety and effectiveness of new treatments. To be valuable, clinical trials must be conducted accordingly to the principles of good clinical practices (GCPs).
Quality Certificate
Quality management system for the medical device industry
ISO 13485:2003, Medical devices – Quality management systems – Requirements for regulatory purposes, is based on quality management system requirements currently contained in medical device regulations around the world, as well as those approprate requirements contained in ISO 9001.
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