Medical Writing Medical Devices 2017 Does standardisation improve animal testing of medical devices?

Volume 26, Issue 2 - Medical Devices 2017

Does standardisation improve animal testing of medical devices?



Compliance with European regulatory standards in animal research could be viewed as a way of dotting the i’s and crossing the t’s, rather than actually holding the research to scientific scrutiny. Standardisation is important and needs improvement for in vivo testing of medical devices, so that it can be more than basic guidelines. Innovative research must go beyond the requirements set out in regulatory standards to enable research practices to be improved and updated
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  1. De Jong WH, Carraway JW, Geertsma RE. In vivo and in vitro testing for the biological safety evaluation of biomaterials and medical devices. Biocompatibility and Performance of Medical Devices. 2012; 120–58 Available from: http://
  2. Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices. OJ L. 1990; 189: 17 Available from: 1990L0385:20071011:en:PDF
  3. Council Directive 93/42/EEC concerning medical devices. OJ L. 1993; 169: 1. Available from: 1993L0042:20071011:en:PDF
  4. Council Directive 98/79/EC on in vitro diagnostic medical devices. OJ L. 1998; 331:1 Available from: 31998L0079&from=EN
  5. ISO 13485. Medical devices. Quality management systems. Requirements for regulatory purposes. 2016 Available from:
  6. ISO 10993-6. Biological evaluation of medical devices. Tests for local effects after implantation. 2016. Available from:
  7. Derveaux S, Vandesompele J, Hellemans J. How to do successful gene expression analysis using real-time PCR. Methods. 2010;50(4):227–30 Available from: http://
  8. BS EN ISO 10993-11. Biological evaluation of medical devices. Tests for systemic toxicity. 2006. Available from:
  9. Whittaker JP, Charron KD, McCalden RW, Macdonald SJ, Bourne RB. Comparison of steady state femoral head penetration rates bet ween two highly cross-linked poly ethy - lenes in total hip arthroplasty. J Arthro - plasty. 25(5):680-6, 2010 Available from: http://
  10. ISO 10993-5. Biological evaluation of medical devices. Tests for in vitro cytotoxicity. 2009 Available from: standard/36406.html



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Abstracts from 44th EMWA conference Poster session
News from the EMA
Journal Watch
Gained in Translation
Getting Your Foot in the Door
In the Bookstores
Regulatory Matters
The Webscout
Good Writing Practice
Out on Our Own


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Editoral Board


Raquel Billiones


Evguenia Alechine

Jonathan Pitt

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Victoria White

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Claire Chang

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Gained in Translation

Ivana Turek

Getting Your Foot in the Door

Wendy Kingdom / Amy Whereat

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Alison McIntosh 

In the Bookstores

Maria Kołtowska-Häggström

Lingua Franca and Beyond

Maddy Dyer


Lisa Chamberlain-James

Medical Communications/Writing for Patients

Payal Bhatia

Medical Devices

Evguenia Alechine

My First Medical Writing

Anuradha Alahari

News from the EMA

Adriana Rocha


Tiziana von Bruchhausen


Clare ChangZuo Yen Lee 

Regulatory Matters

Sam Hamilton

Regulatory Public Disclosure

Claire Gudex

Teaching Medical Writing

Louisa Ludwig-Begall / Sarah Kabani

The Crofter: Sustainable Communications

Louisa Marcombes

Veterinary Writing

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