Recent Publications

Recent Publications by John       Deavin

  • Regulatory Rapporteur Vol 1 No 2 February 2004 :  Parallel imports of medical devices
  • Regulatory Rapporteur Vol 2 No 4 April 2005: The impact of European medical device legislation on healthcare product development-I
  • Regulatory Rapporteur Vol 2 No 5 May 2005:The impact of European medical device legislation on healthcare product development-II
  • Regulatory Rapporteur Vol 3 No 4 April 2006:The future regulation of Advanced Therapy Products in the EU
  • Regulatory Rapporteur Vol 3 No 12 December 2006:The quality systems approach to good manufacturing practice       in the medical device industry-comparison of ISO 9001: 2000 and ISO 13
  •       GMP Review Volume 6 No 2 July 2007:The quality systems approach to GMP in the medical device industry       -comparison of ISO 9001:2000 and ISO 13485:2003 .
  • GMP Review Volume 6 No 4 January 2008: ISO 15378:2006-a tool for the pharmaceutical industry-a challenge for the medical device industry
  • Regulatory  Rapporteur Vol 5 No 2 February 2008: ISO 15378:2006-a tool for the pharmaceutical industry-a challenge for the medical device industry
  • Regulatory Rapporteur Vol 5 No 10 October 2008:The medicinal product and medical device borderline:exploring the scope and application of the EU Directives
  • Journal of Medical Device Regulation February 2009 Volume 6(1) pp3-13:Medicinal Product and Medical Device Borderline:Exploring the Scope and Application of the EU Directives
  • GMP Review Volume 8 no 1 April 2009:ISO 9001:2008- A review of the latest edition of the Quality Management System Standard
  • Regulatory Rapporteur Vol 6 No 12 December 2009 pp 14-16:The 4th Annual Medical Devices Symposium 2009
  • Regulatory Rapporteur Vol 7 No 1 January 2010 pp 13- 16:The impact of the European Commission Guideline MEDDEV 2.1/3 Revision 3 of the Medicinal Product and Medical Device Borderline
  • Regulatory Rapporteur Vol 8 No 4 April 2011 pp 19-21:Medical Device Vigilance: A Case Study Approach
  • Regulatory Rapporteur Vol 9. No 3. March 2012 pp 20-23 An interpretive view on the definition of ‘metabolic means’ in relation to the drug-device borderline.

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