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Guest - £550.00 - https://buy.stripe.com/3cs4jcawUcI8ds4bIQ

ICR Member - £450.00 - https://buy.stripe.com/dR63f8fRe6jK3Ru3cl

ICR Academic £350.00 - https://buy.stripe.com/28og1U48weQg4VyeV4

This course will run ONLINE VIA ZOOM

Medical Devices have a fundamental role in saving lives by providing innovative healthcare solutions for the diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease. There are over 300 000 types of medical devices on the EU market, examples of which include sticking plasters, contact lenses, X-ray machines, pacemakers, breast implants, software apps and hip replacements. The medical devices sector is essential to the provision of healthcare and is an important player in both the European and global economy.

Released in 2020 the updated ISO14155 standard, which addresses good clinical practice for the design, conduct, recording and reporting of clinical investigations carried out in human subjects to assess the safety or performance of medical devices, has been significantly revised.

Approximately 1.5 million different medical devices are available globally; with thousands of new and innovative medical devices being introduced to the market every year. While there is legislation at the national and regional level ISO 14155 provides a global standard for clinical investigations on human subjects.

Please note: ISO 14155 is only applicable for Medical Devices including diagnostic/imaging devices BUT NOT In Vitro diagnostics (IVD).

To gain a clear understanding of the responsibilities of each of the key stakeholders (Sponsor/Monitor/Investigator) and an appreciation of the impact of the revisions to the updated ISO document and its relationship to the Medical Device Directive (MDD) and Medical Device Regulation (MDR)

The day will be spent reviewing the updated ISO document and its relationship to the Medical Device Directive (MDD) and Medical Device Regulation (MDR). This will enable you to go away with a clear understand the responsibilities of each of the key stakeholders (Sponsor/Monitor/Investigator) and an appreciation of the impact of the revisions. The day is interactive, and there will be discussion of real life examples enabling you to immediately start implementing the revised Standard in a practical way.