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Staff Publications

Andrews, J., Robinson, R.; "Demystifying Pre-Production Design Control for Marketing in the USA – How Does it Fit Into Early Product Development?" Reprinted with permission of Global Regulatory Press (www.globalregulatorypress.com)

Robinson, R.; "The FDA Amendments Act of 2007 - More than Just Medical Device User Fees" Journal of Medical Device Regulation, February 2008. Reprinted with permission of Global Regulatory Press (www.globalregulatorypress.com)

Robinson, R.; "Update on the FDA Medical Device User Fee Programme"
Journal of Medical Device Regulation, November 2007. Reprinted with permission of Global Regulatory Press (www.globalregulatorypress.com)

Robinson, R.; "Update on the US FDA Medical Device User Fees" Journal of Medical Device Regulation, August 2007. Reprinted with permission of Global Regulatory Press (www.globalregulatorypress.com) Download PDF (140KB)

Robinson, R.; "Is it Time for Academic Preparation of Future Regulatory Affairs Professionals?" Journal of Medical Device Regulation, May 2006. Reprinted with permission of Global Regulatory Press (www.globalregulatorypress.com)

Robinson, R.; "US FDA Regulation of Combination Products" Journal of Medical Device Regulation, November 2005. Reprinted with permission of Global Regulatory Press (www.globalregulatorypress.com)

Robinson, R.; "CDRH Third Party Review Program" Journal of Medical Device Regulation, February 2005. Reprinted with permission of Global Regulatory Press (www.globalregulatorypress.com)

Andrews, J.; "10 Tips for Effective Design Controls," Medical Design, March 2005.

Robinson, R.; "Nonclinical Development Activities for Medical Devices" Regulatory Affairs Focus, July 2004.

Hemeon-Heyer, S., Robinson R.; "Abbreviated and Special 510(k)s: How to Use Alternative Approaches to Speed Product Clearance" Medical Product Outsourcing, Vol. 2, No. 3, May/June 2004.

Hemeon-Heyer, S., Robinson R.; "Preparing a Successful 510(k) Submission" Medical Product Outsourcing, Vol. 2, No. 2, March/April 2004.

Robinson, R.; "Nontraditional Patient Care - Regulatory Affairs Positions Offer Alternatives to Bedside Care" Advance for Nurses, Online Edition, March 2003.

Nolte, C.J.M, McNamara-Cullinane, M.; "Foreign Establishment Registration and United States Agent Requirement," Medical Device Technology, Vol. 13, No. 10, December 2002.

Sullivan, T. E.; "Update: FDA Regulation of Reprocessing Devices Labeled for Single Use," BioFeedback, Vol. 29, No.1, Winter 2000.

Sullivan, T. E.; "Re-Processing Single-Use Devices: An Update," Journal of cGMP Compliance, Vol. 5, No.1, October 2000.

Robinson, R.; "Finally and hopefully, equal treatment under the law: the FDA's proposed strategy for regulating reuse of single use devices," Clinica, 911: 6-7, June 12, 2000.

Nolte C.J.M.; McNamara-Cullinane, M., "New Routes to the United States: States and Abbreviated 510(k)s," Devices Technology, 11 (3):38-40, April 2000

Robinson, R.; "The Proposed FDA Strategy for Regulation of the Reuse of Single Use Medical Devices." Regulatory Affairs Focus, 5 (4):10-15, April 2000.

Hayden, C., Feldstein M., "Dealing with discrepancy analysis/Part 2: Alternative analytical strategies," IVD Technology, March/April 2000.

Nolte, C.J.M.; "Implementation of the New 510(k) Paradigm" Regulatory Affairs Focus, 5(2): 30-34, February 2000.

Sullivan, T.E.; "Re-Engineering the Registration and Listing Process," ASQ Biomedical Division Quarterly Newsletter, BioFeedback,"Autumn 1999 edition.

Nolte, C.J.M.; "Preparation of 510(k) Premarket Notifications for an Already Marketed Device," FDA Regulatory & Quality Advisor, Volume 6, Number 3, March 1999.

Sullivan, T.E.; "Revisions to FDA Medical Device Inspection Practices," Journal of cGMP Compliance, Volume 3, No. 2, January 1999.

Sullivan, T.E.; "Medical Devices: Reports of Corrections and Removals," ASQ Biomedical Division Quality Controller Newsletter, Volume 27, Number 1, Winter 1998.

Hayden, C.; Feldstein, M; "Design Considerations for IVD Clinical Trials: Time-Staggered Multiple End Points and Time Related Issues," IVD Technology, Volume 4, Number 3, May/June 1998.

Robinson, R.; "Nurses in Regulatory Affairs - Non-Traditional Patient Care," Regulatory Affairs Focus, Volume 4, Number 4, April 1998.

Sheeron, S.C.; "Monitoring Studies of Devices and Drugs - What's the difference?" Applied Clinical Trials, Volume 6, Number 11, November 1997.

Sullivan, T.E.; "A Discussion of Possible Effects of the New Regulation on PMA Manufacturing Section Submissions and Inspections," Journal of cGMP Compliance, Volume 2, Number 1, October 1997.

Nolte, C.J.M.; "Common Regulatory Deficiencies in Medical Device Clinical Studies," Applied Clinical Trials, Volume 6, Number 9, September 1997.

Webster, J.L.; "Medical Devices, Promotion, Labelling and Advertising," Regulatory Affairs Focus, Volume 2, Number 6, June 1997.

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