MedDEV Quarterly News: Current Issue Q1/21

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MedDEV Quarterly News Q1/21 – Featured Publication Single Release:

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Applying S.P.E.L. (safety and performance evidence level) standard to patient matched medical devices: The need for a transparent regulatory matrix to qualify new manufacturing methods and technologies


Dietmar Schaffarczyk 1,2,*; Christoph Koslowski 2; Andreas Schwitalla 3; Dieter Scholl 1; Ingo Hämmerle 4, Sebastian Spintzyk 5; Sonia Seubert 6
1 QS Quality Services Ltd., Certification Body, 3, Triq G. Flores, advanced centre, Santa Venera SVR 1950, Malta
2 stimOS GmbH, Byk-Gulden-Str. 2, 78467 Konstanz
3 Charité – Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Dental Materials and Biomaterial Research, Department of Prosthodontics, Geriatric Dentistry and Craniomandibular Disorders, Aßmannshauser Str. 4-6, 14197 Berlin, Germany
4 Medical Innovation Incubator, Tübingen
University Hospital Tübingen, Section Medical Materials Science and Technology, Osianderstr. 2-8, 72076 Tuebingen
6 Mazars Rechtsanwaltsgesellschaft mbH, Berlin

The use of direct and indirect KPIs in decision making: A case study for spinal implants and their possible impact to the market:

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New Quality Standard S.P.E.L. put effective for surface functionalization technologies:

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Additive manufacturing: 3D printing technologies result in different mechanical properties by varying manufacturing parameters:

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