White Papers

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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Restricted Substances EU MDR

Medical Devices placed on the EU market must comply with both the Medical Devices Regulation (MDR) 2017/745/EU and the Restriction of the use of certain Hazardous Substances (RoHS) Directive 2011/65/EU and its amendments. Both include substance restrictions but the approaches used are very different.

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Use of Retrospective RWD for MDR Compliance

As EU MDR has already entered into force and will be applicable in May 2020,the device companies are getting geared up to be MDR compliant. EU MDR enforces stringent requirements related to clinical evidence.

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UDI in new EU MDR

Unique Device Identification (UDI) is intended to assign a unique identifier to medical devices within the United States it marks and identifies individual medical devices throughout their distribution and product life.

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