LRQA is a proud sponsor of 2013 RAPS: the Regulatory Convergence.
Visit us at stand 2236
If you're a CEO, director, specialist, consultant or industry professional working in research, clinical, pharma, medical devices, biologics, compliance, from all different stages of the regulatory spectrum and product lifecycle, you don't want to miss this event.
The Regulatory Convergence is a place where visionaries, leaders and thinkers come to figure out how to turn drive into action. A place to find out more and push things further.
Mark your calendar for LRQA's speaking session on Monday 30 September, 10:15–11:00 am
Session Title: Harmonized Standards – Are They Fit For Purpose?
Track: Medical Devices & In Vitro Diagnostics
Recent publications of harmonized standards, such as EN ISO13485 and EN ISO14971, have included annex Z’s intent to identify where the standards do not meet the essential requirements of the European Medical Device Directives. While a standard should provide a clear method of application, ensuring a uniform approach by manufacturers and regulatory organizations, these annexes leave room for interpretation. As a result, different manufacturers have interpreted and applied the standards differently.