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Whitepapers


Clinical Data for MDR/IVDR, Make it Easy with Real World Approach

Real World Data and Evidence (RWD/RWE) provide real picture of how the approved or marketed product is used by HCPs and their patients.

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PMS Planning and Challenges under EU MDR

Post Market Surveillance, as described in the EU MDR Medical Device Regulation, is a new concept. A manufacturer shall know at all times how his product performs in the field.

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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.

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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.

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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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