Volume 26, Issue 2 - Medical Devices
Does standardisation improve animal testing of medical devices?
Author: Jayna Patel
Abstract
Abstract
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
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
Download the full article
References
- 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://
- 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: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CONSLEG: 1990L0385:20071011:en:PDF
- Council Directive 93/42/EEC concerning medical devices. OJ L. 1993; 169: 1. Available from: http://eur-lex.europa.eu/LexUriServ/ LexUriServ.do?uri=CONSLEG: 1993L0042:20071011:en:PDF
- Council Directive 98/79/EC on in vitro diagnostic medical devices. OJ L. 1998; 331:1 Available from: http://eur-lex.europa.eu/legalcontent/EN/TXT/HTML/?uri=CELEX: 31998L0079&from=EN
- ISO 13485. Medical devices. Quality management systems. Requirements for regulatory purposes. 2016 Available from: https://www.iso.org/standard/59752.html
- ISO 10993-6. Biological evaluation of medical devices. Tests for local effects after implantation. 2016. Available from: https://www.iso.org/standard/61089.html
- 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://
- BS EN ISO 10993-11. Biological evaluation of medical devices. Tests for systemic toxicity. 2006. Available from: https://www.iso.org/standard/35977.html
- 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://
- ISO 10993-5. Biological evaluation of medical devices. Tests for in vitro cytotoxicity. 2009 Available from: https://www.iso.org/ standard/36406.html
Visit the EMWA website
Search
Articles
Medical Devices: An exciting industry at a crossroads
President's Message
EMWA News
Writing for medical devices compared to pharmaceuticals: An introduction
Clinical Evaluation Reports from the medical writer’s perspective!
New EU medical device regulations: Impact on the MedTech sector
Medical Device Regulation: A necessary step towards more patient and user safety
Transparency – left to its own devices until now
Medical devices in the disclosure era and the role of medical writers
Does standardisation improve animal testing of medical devices?
Puns, promises, and metaphors: Medical device trade names
French breast implants, the Medical Device Regulation, and a theoretical case study
Science journalism: In search of a new identity
Can a medical writer submit a manuscript on behalf of a corresponding author?
To be or not to be – Are medical and scientific writers of non-native English origin at a disadvantage?
Winners of the Geoff Hall Scholarship Essay Competition
Good medical writing saves lives: The perspective of a former medic
Good medical writing saves lives – and even a little comma can make a difference
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
Profile
Out on Our Own
Member Login
Links
Editoral Board
Editor-in-Chief:
- Phillip Leventhal (4Clinics, Lyon, France)
Co-Editor:
- Evguenia Alechine
- Stephen Gilliver (TFS Trial Form Support, Lund, Sweden)
Managing Editor
- Victoria White (Tampa, Florida, USA) Email: MEW@emwa.org
show all +
Associate Editors:
- Anuradha Alahari (PAREXEL International, Paris, France)
- Raquel Billiones (Clinipace, Zurich, Switzerland)
- Barbara Grossman (Hawkeye Medical Limited, Berkshire, UK)
- Joselita T Salita (Freelance, Bremen, Germany)
- Nathan Susnik (Hanover Medical School, Hanover, Germany)
- Clare (Chi-Chih) Chang
- Jonathan Pitt
Section Editors:
- Alison McIntosh (ICON Clinical Research, Hampshire, UK)
- Wendy Kingdom (Wendy Kingdom Ltd., Dulverton, UK)
- Lisa Chamberlain-James (Trilogy Writing and Consulting, Norfolk, UK)
- Maria Koltowska-Haggstrom (Proper Medical Writing Warsaw, Poland)
- Laura Collada Ali (Teksema, Cogne, Italy)
- Hervé Maisonneuve (Freelance, Lyon, France)
- Satyen Shenoy (Describe Scientific Writing & Communications, Cologne, Germany)
- Claire Gudex (Klinisk Institut, Odense, Denmark)
- Beatrix Doerr
- Sam Hamilton (Newcastle Upon Tyne, UK)
Ad-hoc Editors:
- Amy Whereat (SpeaktheSpeech Consulting, Asnieres sur Seine, France)
Editor Emeritus:
- Elise Langdon-Neuner (Medical University of Vienna, Austria)