Tag Archives: Premarket Study

6 MONTHS LEFT UNTIL MDR: MORE TIME FOR YOUR CLINICAL EVALUATION?

Update 27-NOV-2019: The EU commission issued a second corrigendum, which upon acceptance by the parliament will give manufacturers of Class I medical devices 4 years extra to bring their clinical evaluation in order, putting them in the same position as … Continue reading

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A NEW VERSION OF ISO 14155: WHAT TO EXPECT?

The MDR as well as the current version of MEDDEV 2.7/1 reference ISO 14155 as GCP standard for medical device clinical investigations. Indeed, the 2011 version, but the third edition is in the making, so it can be good to … Continue reading

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CLINICAL EVIDENCE DILEMMAS: CONTROLLED CLINICAL TRIAL OR DAILY PRACTICE?

Designing a clinical study, often faces discussions that can be traced back to the type of clinical evidence one is looking for: Are you aiming to evaluate the product effect in a controlled clinical study environment, or in a real … Continue reading

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