相似文献
1
Guest Editorial: New Medical Device Regulation in Europe: A Collaborative Effort of Stakeholders to Improve Patient Safety.客座编辑：欧洲新的医疗器械法规：利益相关者为提高患者安全而开展的合作。
Clin Orthop Relat Res. 2020 May;478(5):928-930. doi: 10.1097/CORR.0000000000001154.
2
On the new regulation of medical devices in Europe.欧洲医疗器械新法规
Expert Rev Med Devices. 2017 Dec;14(12):921-923. doi: 10.1080/17434440.2017.1407648. Epub 2017 Nov 24.
3
Medical device regulation in Europe - what is changing and how can I become more involved?欧洲的医疗器械监管——有哪些变化以及我如何能更多地参与其中？
EuroIntervention. 2019 Oct 20;15(8):647-649. doi: 10.4244/EIJV15I8A118.
4
How can we get high quality routine data to monitor the safety of devices and procedures?我们如何获取高质量的常规数据来监测设备和程序的安全性？
BMJ. 2013 May 7;346:f2782. doi: 10.1136/bmj.f2782.
5
[Introduction of innovative high-risk medical devices in Europe: are clinical efficacy and safety guaranteed?].[欧洲创新型高风险医疗器械的引入：临床疗效和安全性有保障吗？]
Rev Epidemiol Sante Publique. 2013 Apr;61(2):105-10. doi: 10.1016/j.respe.2012.08.004. Epub 2013 Mar 7.
6
A full-fledged overhaul is needed for a risk and value-based regulation of medical devices in Europe.欧洲需要对医疗器械进行全面的风险和价值为基础的监管改革。
Health Policy. 2013 Nov;113(1-2):38-44. doi: 10.1016/j.healthpol.2013.03.017. Epub 2013 Apr 17.
7
Commentary: Europe needs a central, transparent, and evidence based regulation process for devices.评论：欧洲需要一个针对器械的集中、透明且基于证据的监管程序。
BMJ. 2013 May 7;346:f2771. doi: 10.1136/bmj.f2771.
8
The Quest for Quality: Navigating the Changing Landscape of Healthcare Technology Regulations.对质量的追求：应对不断变化的医疗技术监管格局。
Biomed Instrum Technol. 2018 May/Jun;52(3):182-191. doi: 10.2345/0899-8205-52.3.182.
9
European medical device regulation: Perfection is achieved, not when there is nothing more to add, but when there is nothing left to take away.欧洲医疗器械法规：臻于完美，并非在于无可增添，而是在于无可删减。
Clin Neurophysiol. 2024 Jul;163:265-266. doi: 10.1016/j.clinph.2024.04.009. Epub 2024 Apr 19.
10
Impact of the new European medical device regulation: a two-year comparison.新欧洲医疗器械法规的影响：两年比较。
Biomed Tech (Berl). 2023 Nov 13;69(3):317-326. doi: 10.1515/bmt-2023-0325. Print 2024 Jun 25.
引用本文的文献
1
Approaching 3D printing in oral and maxillofacial surgery - suggestions for structured clinical standards.口腔颌面外科学中的 3D 打印技术——结构化临床标准建议。
Oral Maxillofac Surg. 2024 Jun;28(2):795-802. doi: 10.1007/s10006-024-01208-3. Epub 2024 Jan 12.
2
Expanding Quality by Design Principles to Support 3D Printed Medical Device Development Following the Renewed Regulatory Framework in Europe.在欧洲更新的监管框架下，扩展设计质量原则以支持3D打印医疗器械的开发。
Biomedicines. 2022 Nov 16;10(11):2947. doi: 10.3390/biomedicines10112947.
3
A survey regarding the organizational aspects and quality systems of in-house 3D printing in oral and maxillofacial surgery in Germany.德国口腔颌面外科内部 3D 打印的组织方面和质量体系调查。
Oral Maxillofac Surg. 2023 Dec;27(4):661-673. doi: 10.1007/s10006-022-01109-3. Epub 2022 Aug 22.
4
New regulation of medical devices in the EU: impact in dermatology.欧盟医疗器械新法规：对皮肤科的影响。
J Eur Acad Dermatol Venereol. 2022 Mar;36(3):360-364. doi: 10.1111/jdv.17830. Epub 2021 Dec 6.
5
Safety of Medical Devices in Poland - Analysis of Withdrawn and Suspended Certificates of Compliance.波兰医疗器械的安全性——已撤销和暂停的合格证书分析
Med Devices (Auckl). 2021 Jul 26;14:239-247. doi: 10.2147/MDER.S316473. eCollection 2021.
本文引用的文献
1
Transparency of clinical evidence for medical devices in Europe - Authors' reply.欧洲医疗器械临床证据的透明度——作者回复
Lancet. 2019 Apr 27;393(10182):1693-1694. doi: 10.1016/S0140-6736(18)33063-0.
2
Doctors demand to see evidence on safety of medical devices approved in Europe.医生们要求查看在欧洲获批的医疗设备的安全性证据。
BMJ. 2018 Nov 30;363:k5105. doi: 10.1136/bmj.k5105.
3
Medical device industry: international investigation exposes lax regulation.医疗器械行业：国际调查揭示监管不力
BMJ. 2018 Nov 25;363:k4997. doi: 10.1136/bmj.k4997.
4
Europe's new device regulations fail to protect the public.欧洲新的设备法规未能保护公众。
BMJ. 2018 Oct 10;363:k4205. doi: 10.1136/bmj.k4205.
5
The need for transparency of clinical evidence for medical devices in Europe.欧洲医疗器械临床证据透明度的需求。
Lancet. 2018 Aug 11;392(10146):521-530. doi: 10.1016/S0140-6736(18)31270-4. Epub 2018 Jul 17.
6
Faulty hip implant shows up failings of EU regulation.有缺陷的髋关节植入物显示出欧盟监管的不足。
BMJ. 2012 Oct 23;345:e7163. doi: 10.1136/bmj.e7163.
7
Ongoing problems with metal-on-metal hip implants.金属对金属髋关节植入物的持续问题。
BMJ. 2012 Feb 28;344:e1349. doi: 10.1136/bmj.e1349.
Zotero 插件