Volume 26, Issue 2 - Medical Devices 2017

Writing for medical devices compared to pharmaceuticals: An introduction

Authors: Beatrix Döerr, Sophia Whitman, Steven Walker

Abstract

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References

1. Eur-Lex. Council Directive 93/42/EEC Concerning Medical Devices [cited 2016 Dec 12]. Available from: http://eurlex.europa.eu/legal-content/EN/TXT/ ?uri=CELEX:31993L0042
2. BBC News. Viagra and Other Drugs Discovered by Accident [cited 2016 Dec 21]. Available from: http://news. bbc.co.uk/2/hi/health/8466118.stm
3. The Pharmaceutical Journal. How Minoxidil was Transformed from an Antihypertensive to Hair Loss Drug [cited 2016 Dec 12]. Available from: http://www. pharmaceutical-journal.com/news-andanalysis/news/how-minoxidil-wastransformed-from-an-antihypertensive-tohair-loss-drug/11080942.article
4. ThoughtCo. The History of Aspirin [cited 2017 Jan 03]. Available from: http:// inventors.about.com/od/ famousinventions/fl/The-History-of-Aspirin.htm
5. European Commission. Clinical Evaluation: Guide for Manufacturers and Notified Bodies Under Directives 93/42/EEC and 90/385/EEC [cited 2017 Jan 22] Available from: http://meddev.info/wp-content/uploads/2016/08/MEDDEV_2_7_1.pdf
6. Edwards. Our History. [cited 2017 March 06]. Available from: http://www.edwards. com/aboutus/OurHistory
7. ISO. ISO14155: 2011. Clinical Investigation of Medical Devices for Human Subjects – Good Clinical Practice [cited 2017 Jan 22] Available from: http://www.iso.org/ iso/catalogue_detail?csnumber=45557
8. Stone GW, Adams DH, Abraham WT, Kappetein AP, Genereux P, Vranckx P, et al. Clinical trial design principles and endpoint definitions for transcatheter mitral valve repair and replacement: Part 2: Endpoint definitions: A consensus document from the Mitral Valve Academic Research Consortium. J Am Coll Cardiol 2015;66:308-21 Available from: http://
9. Byrne R Serruys PW, Baumbach A, Escaned J, Fajadet J, James S, et al. Report of a European Society of CardiologyEuropean Association of Percutaneous Cardiovascular Interventions task force on the evaluation of coronary stents in Europe: Executive summary. Eur Heart J 2015; 36:2608-20 Available from: http://
10. Stone GW, Vahanian AS, Adams DH, Abraham WT, Borer JS, Bax JJ, et al. Clinical trial design principles and endpoint definitions for transcatheter mitral valve repair and replacement: Part 1: Clinical trial design principles: A consensus document from the Mitral Valve Academic Research Consortium. J Am Coll Cardiol 2015;66:278-307 Available from: http://
11. Doerr B. Practical guide for writing clinical study protocols for medical devices [cited 2017 Apr 09]. Available from: https://www.emwa.org/training
12. The New England Journal of Medicine. Transcatheter or surgical aortic-valve replacement in intermediate-risk patients [cited 2017 March 06]. Available from: http://www.nejm.org/action/showSupple ments?doi=10.1056%2FNEJMoa1514616 &viewType=Popup&viewClass=Suppl
13. European Commission. Guidelines for Competent Authorities for Making a Validation/Assessment of a Clinical Investigation Application Under Directives 93/42/EEC and 90/385/EEC. [cited 2017 Feb 12]. Available from: http://meddev. info/wp-content/uploads/2016/08/ MEDDEV_2_7_2.pdf
14. Federal Institute for Drugs and Medical Devices. Silicone Gel Breast Implants, from Poly Implant Prothèse Company – Information [cited 2017 Apr 02]. Available from: http://www.bfarm.de/SharedDocs/ Risikoinformationen/Medizinprodukte/ EN/silicone_breast_implants_PIP_info. html
15. Statista. Medtronic’s Number of Employees from 2006 to 2016 [cited 2017 March 06]. Available from: https://www.statista.com/ statistics/241520/net-income-ofmedtronic-since-2006/
16. Walker S, Opie J, Whitman S, Hood K, Critchley W, Houle V, et al. Writing for pharmaceutical or medical device companies: A survey of entry requirements, career paths, quality of life, and personal observations. Medical Writing 2016; 25:21–9. Available from: http://
17. European Commission. Post Market Clinical Follow-Up Studies. A Guide for manufacturers and notified bodies [cited 2017 Jan 22]. Available from: http://meddev.info/wp-content/uploads/ 2016/08/MEDDEV_2_12_2.pdf