White Papers


EU MDR: Medical Device Labeling Changes & Challenges

Global rollout of EU MDR and other UDI-type of regulations are driving all medical device companies to revisit their labeling processes to ensure they are all compliant across the extended supply chain.

Med Devices: PMS/PMCF When AE Reporting is Low

Sample size estimation is an important step before undertaking any clinical study. However, the entire process depends upon the number of patients to be included for the proposed study.

EU MDR: How Are You Covered on NanoMaterials New Requirements?

‘NanoMaterial’ means a natural, incidental or manufactured material containing particles in an unbound state or as an aggregate or as an agglomerate and where, for 50 % or more of the particles in the number size distribution.

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