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EU MDR Gap Analysis | Are You Prepared For Changes?
In the past, due to the relative requirements and processes in place in each area, it has been the conception that it is better for products to enter
Are you ready for MDD to MDR transition?
The MDR will replace the existing Medical Devices Directive (93/42/EEC) [MDD] and the Active Implantable Medical Devices Directive (90/385/EEC)
ISO 14155 Standard vs. FDA Medical Device Regulations
Background The ISO 14155 standards were created to clarify the design, conduct, recording and reporting of clinical investigations carried out in
ISO 14155 Update in 2020
The ISO 14155 standard was released on February 1, 2011 by the the International Organization for Standardization (ISO). This affects all medical
Clinical Investigational Studies in Europe
Many medical device companies think they are ready to conduct clinical investigation studies when they are actually months away from initiating a
TCT Congress | San Diego, California
The Transcatheter Cardiovascular Therapeutics (TCT) meeting is the world’s largest educational meeting specializing in interventional cardiovascular
Is your CER ready for MDR?
The release of the revised guidance regarding Clinical Evaluations (MEDDEV 2.7/1 Rev. 4) in 2016 introduced some significant changes to the process of
Attending LINC Medical Meeting
Leipzig Interventional Course (LINC) is scientific live course designed to provide a global platform permitting the interdisciplinary discussion of
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