Roundtable Participants

A Few Members of ISO Technical Committee 198, Working Group 7, Task Group 1:

Tim Galekop works for Ahlstrom FiberComposites as a medical business manager and has worked in the medical field for more than 25 years. (Ahlstrom manufactures nonwovens and papers for medical applications.) He has been a member of the Dutch Norm group from its foundation, participates in the German DIN and French AFNOR, convenes TC 102 WG 4, and participates in ISO TC 198 WG 7 and CEN TC 205 WG 14.

Paul Fielding is a packaging consultant for DuPont Medical Packaging. He has worked in medical packaging for more than 20 years, working at Rexam Medical Packaging prior to DuPont. For the last 10 years he has concentrated on regulatory affairs, currently serving as chairman of the technical committee of ESPA and as a member of the Environmental Focus Group of EUCOMED. He is also senior UK delegate on CEN TC 102 WG 4 and ISO TC 198 WG 7 and UK delegate on CEN TC 261 SC 4.

Curt Larsen is a packaging consultant for DuPont Medical Packaging. He has more than 30 years experience in sterile medical device packaging for firms such as Medtronic and Zimmer. He is past chairman of ASTM subcommittee F02.6 and present vice chairman of ASTM committee F02. He is a member of ASTM committees D10 and F4. He is a member of AAMI, past cochair of ISO TC 198 WG 7, and coauthor of the initial ISO 11607 draft.

Cathy Nutter is a scientific reviewer in the Office of Device Evaluation, Center for Devices and Radiological Heath (CDRH), FDA. She specifically handles regulatory reviews for medical devices in the Division of Reproductive, Abdominal, and Radiological Devices and other scientific reviews of standards, sterilization processes, microbiological methods, medical packaging, endotoxin testing, reprocessing of medical devices, and other related topics. She has worked for CDRH for 17 years in various positions. Prior to FDA, she worked at the National Institutes of Health.

Michael Scholla is senior consultant for DuPont Medical Packaging and DuPont Medical Fabrics. He joined DuPont in 1988 as a research microbiologist and in 1995 joined DuPont Medical Packaging. A member of AAMI's board of directors, he is cochair of ISO TC 198 WG 7 and chairs two AdvaMed task groups.

John Spitzley is an associate fellow of packaging for Medtronic. A 1968 graduate of the Michigan State University School of Packaging and a Certified Professional by the Institute of Packaging Professionals, he has worked in medical device packaging for 29 years.

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