White Papers


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

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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