Anyone involved with clinical investigation should have a copy of the ISO 14155:2020 standard because it contains everything that is needed on good clinical practice, GCP. But it can be expensive if you buy it in the wrong place.
In this article, you will learn where to buy the standard for a fraction of the price compared to major outlets.
The official ISO website offers PDF, EPUB, redlined, and paper format, and combinations of those for the following prices:
| Format | Language | Price |
|---|---|---|
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PDF+EPUB
|
English / French
|
CHF 198 (EUR ~189)
|
|
PDF+EPUB+REDLINE
|
English / French
|
CHF 238 (EUR ~227)
|
|
PAPER
|
English / French
|
CHF 198 (EUR ~189)
|
There are also other places where you can get access to the ISO 14155:2020, such as:
The good news is that there is a more affordable option and that is buying a copy from the Estonian Centre for standardisation and accreditation. The price there is much lower than on the official ISO website or elsewhere. And the standard is still in English.
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Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020)
|
|
|
PDF
|
EUR 26.58
|
|
PDF+REDLINE
|
EUR 31.90
|
|
PAPER
|
EUR 26.58
|
Take a look at our online Clinical Investigation for Medical Devices and ISO 14155 course that focuses on good clinical practice (GCP) for the design, conduct, recording, and reporting of clinical investigations carried out on human subjects to assess the clinical performance or effectiveness and safety of medical devices.
The course covers an orientation of the clinical investigation process according to the EN ISO 14155:2020 standard and the standard’s relation to MDCG guidance documents. This practical course is suitable for anyone working in clinical research and medical device development, such as regulatory affairs associates, QA engineers, and clinical research specialists.
Maria Nyåkern, Ph.D., is a clinical research expert, consultant, and educator specialising in medical device clinical investigations. She is the founder of a prominent medical device CRO and has supported early-stage start-ups to large multinational organisations, setting up and managing clinical investigations involving tens of thousands of patients, including projects for many of the world’s leading medical device manufacturers.
She is an international expert and a Swedish representative on the ISO technical committees SIS/TK 340 and ISO/TC 194 (Biological and clinical evaluation of medical devices), contributing to the development of ISO 14155 and ISO 18969. Maria specialises in clinical evaluation and clinical investigations in accordance with EU MDR 2017/745 and ISO 14155 and ISO 18969.
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Plan, manage, and monitor clinical investigations aligned with ISO 14155 and GCP; from clinical sites to data reporting.
