Medical Device Obligations Taskforce

Deliverables

Documents, reports (7)

Life Cycle Acceleration

Study on the use of extendedparameter life cycle acceleration with the described parameters and possible modellings

Nebulizer Verification

Nebulizer Verification The verification study report will contain the necessary data about aerosol size distribution dose and dose rate The report will be generated under GLP conditions M35

Generalized requirements for material-related tests for medical devices

The document is outlining a set of test requirements for materialrelated tests based on related standards and regulations Tests described in the deliverable are addressing concrete applications from a set of predefined application domains but are formulized in a general manner so that they can be transferredadapted to other domains easily M36

Test Bed verification

Verification and Validation Documentation Test Bed The Documents reports contain the results of the verification testing and validation procedure M26

Collection of Use-Cases and High-Level Design

Collection and documentation of relevant use cases and a high-level design that describe the scope of database and the Blockchain solution enabling the exchange of data on common parts/materials and test beds for conformity assessment of medical devices. (M15)

Vocabulary and Ontology

Definition and documentation of vocabularies and ontologies to enable data exchange and data analysis within and between databases in Version 10 M24

Local Probe Testing

Report on the local probe testing device together with a description of procedures and first data obtained with material libraries

Other (1)

Design & Process Prognosis

Software module predicting design and process dependent degradation processes

Publications

Peer reviewed articles (11)

Novel Test Bench for Inhaler Characterization Including Real-Time Determination of Output, Output Rate, and Liquid Water Content of Delivered Aerosols

Author(s): Felix C. Wiegandt, Ulrich P. Froriep, Theodor Doll, Andreas Dietzel, Gerhard Pohlmann
Published in: Journal of Aerosol Medicine and Pulmonary Drug Delivery, 2020, ISSN 1941-2711
Publisher: Mary Ann Liebert Inc.
DOI: 10.1089/jamp.2020.1611

Combinatorial Passivation Study in the Aluminium-Samarium System for Basic Property Mapping and Identification of Secondary Phase Influence

Author(s): Yudai Yamamoto, Andrei Ionut Mardare, Jan Philipp Kollender, Cezarina Cela Mardare, Dominik Recktenwald, Koji Fushimi, Achim Walter Hassel
Published in: Journal of The Electrochemical Society, 2021, ISSN 0013-4651
Publisher: Electrochemical Society, Inc.
DOI: 10.1149/1945-7111/abd1ed

A theoretical and experimental framework for the formation of mixed anodic films on combinatorial aluminium-cerium alloys

Author(s): Khurram Shahzad, Shaukat Ali Lone, Cezarina Cela Mardare, Andrei Ionut Mardare, Achim Walter Hassel
Published in: Electrochimica Acta, 2020, ISSN 0013-4686
Publisher: Pergamon Press Ltd.
DOI: 10.1016/2020.137173

Numerical Evaluation on Residual Thermal Stress-Induced Delamination at PDMS–Metal Interface of Neural Prostheses

Author(s): Yuyang Mao, Ivan Pechenizkiy, Thomas Stieglitz, Theodor Doll
Published in: Micromachines, 2021, ISSN 2072-666X
Publisher: Multidisciplinary Digital Publishing Institute (MDPI)
DOI: 10.3390/mi12060669

Breath-Triggered Drug Release System for Preterm Neonates.

Author(s): Felix C Wiegandt; Ulrich P. Froriep; Fabian Muller; Theodor Doll; Theodor Doll; Andreas Dietzel; Gerhard Pohlmann
Published in: Pharmaceutics, 1, 2021, ISSN 1999-4923
Publisher: Multidisciplinary Digital Publishing Institute (MDPI)
DOI: 10.3390/pharmaceutics13050657

Laser-Facilitated Additive Manufacturing Enables Fabrication of Biocompatible Neural Devices

Author(s): Ailke Behrens, Jan Stieghorst, Theodor Doll, Ulrich P. Froriep
Published in: Sensors, 2020, ISSN 1424-8220
Publisher: Multidisciplinary Digital Publishing Institute (MDPI)
DOI: 10.3390/s20226614

The parallels between particle induced lung overload and particle induced periprosthetic osteolysis (PPOL)

Author(s): Paul J. A. Borm
Published in: Open Research Europe, 1, 2021, ISSN 2732-5121
Publisher: Open Research Europe
DOI: 10.12688/openreseurope.13264.1

Mixed oxide growth on combinatorial aluminium–gadolinium alloys — a thermodynamic and first-principles approach

Author(s): Khurram Shahzad, Cezarina Cela Mardare, Andrei Ionut Mardare, Achim Walter Hassel
Published in: Journal of Solid State Electrochemistry`, 2021, ISSN 1432-8488
Publisher: Springer Verlag
DOI: 10.1007/s10008-021-05012-x

Predicting Corrosion Delamination Failure in Active Implantable Medical Devices: Analytical Model and Validation Strategy

Author(s): Adrian Onken, Helmut Schütte, Anika Wulff, Heidi Lenz-Strauch, Michaela Kreienmeyer, Sabine Hild, Thomas Stieglitz, Stefan Gassmann, Thomas Lenarz, Theodor Doll
Published in: Bioengineering, 2021, ISSN 2306-5354
Publisher: MDPI
DOI: 10.3390/bioengineering9010010

Impact of Femtosecond Laser Treatment Accompanied with Anodization of Titanium Alloy on Fibroblast Cell Growth

Author(s): Shaukat Ali Lone, Martina Muck, Peter Fosodeder, Cezarina Cela Mardare, Camilo Florian, Agnes Weth, Jörg Krüger, Clemens Steinwender, Werner Baumgartner, Jörn Bonse, Johannes Heitz, Achim Walter Hassel
Published in: physica status solidi (a), 217/13, 2020, Page(s) 1900838, ISSN 1862-6300
Publisher: Wiley - V C H Verlag GmbbH & Co.
DOI: 10.1002/pssa.201900838

Detection of Breathing Movements of Preterm Neonates by Recording Their Abdominal Movements with a Time-of-Flight Camera.

Author(s): Felix C Wiegandt; David Biegger; Jacob Friedemann Fast; Grzegorz Matusiak; Jan Mazela; Tobias Ortmaier; Theodor Doll; Andreas Dietzel; Bettina Bohnhorst; Gerhard Pohlmann
Published in: Pharmaceutics, 2021, ISSN 1999-4923
Publisher: Multidisciplinary Digital Publishing Institute (MDPI)
DOI: 10.3390/pharmaceutics13050721