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ISO - ISO 14155:2020 - Clinical investigation of medical …
- https://www.iso.org/standard/71690.html
- This document addresses good clinical practice for the design, conduct, recording and reporting of clinical investigations carried out in human subjects to …
ISO - ISO 14155:2011 - Clinical investigation of medical …
- https://www.iso.org/standard/45557.html
- ISO 14155:2011 addresses good clinical practice for the design, conduct, recording and reporting of clinical investigations carried out in human subjects to assess the safety or …
Clinical investigation of medical devices for human subjects …
- https://cdn.standards.iteh.ai/samples/71690/25a77f3da580409f87d1ad81dadd4db0/ISO-14155-2020.pdf
- Clinical investigation of medical devices for human subjects — Good clinical practice Investigation clinique des dispositifs médicaux pour sujets humains — Bonne pratique …
How to Plan and Conduct an ISO 14155-Compliant …
- https://www.greenlight.guru/blog/iso-14155
- ISO 14155:2020 provides the general specifications and requirements for clinical investigations of medical devices. The latest version of the standard was published in 2020 and is intended to serve …
ISO 14155: Clinical Investigation of Medical Devices for …
- https://link.springer.com/chapter/10.1007/978-3-030-91855-2_1
- ISO 14155: Clinical Investigation of Medical Devices for Human Subjects Abstract. ISO 14155 is formulated to define good clinical practice during clinical …
ISO - ISO 14155-1:2003 - Clinical investigation of …
- https://www.iso.org/standard/31723.html
- ISO 14155-1:2002 defines procedures for the conduct and performance of clinical investigations of medical devices. It specifies general requirements intended to: protect …
ISO - ISO 14155:1996 - Clinical investigation of medical …
- https://www.iso.org/standard/23736.html
- Abstract. Pertains to the clinical investigation in human subjects of those medical devices whose clinical performance needs assessment. Specifies the requirements for conducting …
ISO 14155:2011 Clinical Investigation of medical …
- https://www.imdrf.org/sites/default/files/docs/imdrf/final/meetings/imdrf-meet-160913-brazil-iso14155-2011.pdf
- This International Standard addresses good clinical practice for the design, conduct, recording and reporting of clinical investigations carried out in human subjects to assess …
Clinical Investigation of Medical Devices and ISO 14155 …
- https://medicaldevicehq.com/introduction-to-clinical-investigations-of-medical-devices-and-iso-14155-online-course/
- Maria Nyåkern is part of the ISO committee, SIS/TK 340 and ISO/TC 194 Biological and clinical evaluation of medical devices, responsible for developing the ISO 14155 …
ISO/DIS 11979-7 (en), Ophthalmic implants — …
- https://www.iso.org/obp/ui/#!iso:std:79689:en
- ISO 14155, Clinical investigation of medical devices for human subjects — Good clinical practice ISO 14971, Medical devices — Application of risk management to medical …
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