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March 28, 2019

Event summary on MedTech.Factory: Medical Device Regulation

On March 21, 2019, more than 40 interested participants from industry and research participated in the "MedTech.Factory: MDR - where do we stand now?" organized by the Medical Technology Cluster Upper Austria, Business Agency Austria
March 26, 2019

TÜV SÜD 12th Medical Device Forum

At the 12th, organized by TÜV SÜD, representatives of the authorities, TÜV SÜD experts, medical device manufacturers and consultants discuss the most important changes brought about by the European Medical Devices Regulation and outline possible concepts for how to implement the new regulatory requirements efficiently.
March 19, 2019

RAPS welcomed its 2019 Board of Directors

Executive Director & Partner at Qserve Group, Dr. Gert Bos, has been appointed President Elect of the RAPS. Gert shares his thoughts about this significant step.

March 18, 2019

Clinical Evaluation - Compliance to MEDDEV 2.7/1 Rev 4 and MDR 2017/745

The clinical team at Qserve has been busy providing trainings at manufacturer locations and writing MEDDEV and MDR compliant CEPs and CERs. On February 27th, Jasmin Hunter presented a 1-hour version of a 2.5-day Clinical Evaluation Workshop for ASQ Biomedical Division of the New England Discussion Group. 
March 18, 2019

New FDA Clinical Investigation Data Requirements in Effect

On February 21, 2019 the new rule allowing clinical data from clinical investigations from outside the United States (OUS) (21 CFR part 814) and new acceptance criteria in 21 CFR parts 807 and 812 Subpart B set forth last year went into effect. 

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