327 related articles for article (PubMed ID: 35872025)
1. Analysis of the renewed European Medical Device Regulations in the frame of the non - EU regulatory landscape during the COVID facilitated change.
Kanti SPY; Csóka I; Adalbert L; Jójárt-Laczkovich O
J Pharm Sci; 2022 Oct; 111(10):2674-2686. PubMed ID: 35872025
[TBL] [Abstract][Full Text] [Related]
2. ISO 15189 is a sufficient instrument to guarantee high-quality manufacture of laboratory developed tests for in-house-use conform requirements of the European
Vanstapel FJLA; Orth M; Streichert T; Capoluongo ED; Oosterhuis WP; Çubukçu HC; Bernabeu-Andreu FA; Thelen M; Jacobs LHJ; Linko S; Bhattoa HP; Bossuyt PMM; Meško Brguljan P; Boursier G; Cobbaert CM; Neumaier M
Clin Chem Lab Med; 2023 Mar; 61(4):608-626. PubMed ID: 36716120
[TBL] [Abstract][Full Text] [Related]
3. Medical Device Regulations and custom-made device documentation: Ten frequently asked questions and their answers.
Green JIJ
Prim Dent J; 2022 Jun; 11(2):22-31. PubMed ID: 35658659
[TBL] [Abstract][Full Text] [Related]
4. Medical Device Regulations and custom-made device documentation: A further ten frequently asked questions and their answers.
Green JIJ
Prim Dent J; 2023 Mar; 12(1):43-50. PubMed ID: 36916619
[TBL] [Abstract][Full Text] [Related]
5. Legal regulation of the production and trade of medical devices and medical equipment in the EU and US: experience for Ukraine.
Pashkov V; Kotvitska A; Harkusha A
Wiad Lek; 2017; 70(3 pt 2):614-618. PubMed ID: 28713093
[TBL] [Abstract][Full Text] [Related]
6. Implementing the new European Regulations on medical devices-clinical responsibilities for evidence-based practice: a report from the Regulatory Affairs Committee of the European Society of Cardiology.
Fraser AG; Byrne RA; Kautzner J; Butchart EG; Szymański P; Leggeri I; de Boer RA; Caiani EG; Van de Werf F; Vardas PE; Badimon L
Eur Heart J; 2020 Jul; 41(27):2589-2596. PubMed ID: 32484542
[TBL] [Abstract][Full Text] [Related]
7. A review of medical device regulations in India, comparison with European Union and way-ahead.
Manu M; Anand G
Perspect Clin Res; 2022; 13(1):3-11. PubMed ID: 35198422
[TBL] [Abstract][Full Text] [Related]
8. Advisory opinion of the AWMF Ad hoc Commission In-vitro Diagnostic Medical Devices regarding in-vitro diagnostic medical devices manufactured and used only within health institutions established in the Union according to Regulation (EU) 2017/746 (IVDR).
Hoffmüller P; Brüggemann M; Eggermann T; Ghoreschi K; Haase D; Hofmann J; Hunfeld KP; Koch K; Meisel C; Michl P; Müller J; Müller C; Rabenau HF; Reinhardt D; Riemenschneider MJ; Sachs UJ; Sack U; Stenzinger A; Streichert T; von Neuhoff N; Weichert W; Weinstock C; Zimmermann S; Spitzenberger F;
Ger Med Sci; 2021; 19():Doc08. PubMed ID: 34194291
[TBL] [Abstract][Full Text] [Related]
9. Comparison of the international regulations for medical devices-USA versus Europe.
Fink M; Akra B
Injury; 2023 Oct; 54 Suppl 5():110908. PubMed ID: 37365092
[TBL] [Abstract][Full Text] [Related]
10. Medical Device Regulation: Requirements for Dental Professionals Who Prescribe and Manufacture Custom-Made Devices.
Green JIJ
Prim Dent J; 2021 Mar; 10(1):64-88. PubMed ID: 33722134
[TBL] [Abstract][Full Text] [Related]
11. Medical device regulation (MDR) in health technology enterprises - perspectives of managers and regulatory professionals.
Huusko J; Kinnunen UM; Saranto K
BMC Health Serv Res; 2023 Mar; 23(1):310. PubMed ID: 36997978
[TBL] [Abstract][Full Text] [Related]
12. An accelerated access pathway for innovative high-risk medical devices under the new European Union Medical Devices and health technology assessment regulations? Analysis and recommendations.
Tarricone R; Banks H; Ciani O; Brouwer W; Drummond MF; Leidl R; Martelli N; Sampietro-Colom L; Taylor RS
Expert Rev Med Devices; 2023 Apr; 20(4):259-271. PubMed ID: 36987818
[TBL] [Abstract][Full Text] [Related]
13. New European medical device regulation: How the French ecosystem should seize the opportunity of the EUDAMED and the UDI system, while overcoming the constraints thereof.
Camus D; Thiveaud D; Josseran A;
Therapie; 2019 Feb; 74(1):73-85. PubMed ID: 30598315
[TBL] [Abstract][Full Text] [Related]
14. Medical device legislation for custom-made devices after the UK has left the EU: answers to a further ten important questions.
Green JIJ
Br Dent J; 2023 Aug; 235(3):205-210. PubMed ID: 37563399
[TBL] [Abstract][Full Text] [Related]
15. [Diagnostic kits in parasitology: which controls?].
Rossi P
Parassitologia; 2004 Jun; 46(1-2):145-9. PubMed ID: 15305705
[TBL] [Abstract][Full Text] [Related]
16. New European Union Regulations Related to Whole Slide Image Scanners and Image Analysis Software.
García-Rojo M; De Mena D; Muriel-Cueto P; Atienza-Cuevas L; Domínguez-Gómez M; Bueno G
J Pathol Inform; 2019; 10():2. PubMed ID: 30783546
[TBL] [Abstract][Full Text] [Related]
17. A review of international medical device regulations: Contact lenses and lens care solutions.
Zaki M; Pardo J; Carracedo G
Cont Lens Anterior Eye; 2019 Apr; 42(2):136-146. PubMed ID: 30446241
[TBL] [Abstract][Full Text] [Related]
18. Unique device identification and traceability for medical software: A major challenge for manufacturers in an ever-evolving marketplace.
Bianchini E; Francesconi M; Testa M; Tanase M; Gemignani V
J Biomed Inform; 2019 May; 93():103150. PubMed ID: 30878617
[TBL] [Abstract][Full Text] [Related]
19. Gastrointestinal endoscopy devices and the European Union Medical Device Regulation: European Society of Gastrointestinal Endoscopy (ESGE) Position Statement.
Bretthauer M; Mori Y; Zessner-Spitzenberg J; Kaminski MF; Siersema PD; Ponchon T; Messmann H; Gralnek IM; Bisschops R; Hassan C
Endoscopy; 2023 Jun; 55(6):578-581. PubMed ID: 37080238
[TBL] [Abstract][Full Text] [Related]
20.
; ; . PubMed ID:
[No Abstract] [Full Text] [Related]
[Next] [New Search]
