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DTA Regulatory Affairs and Standards Committee Update March 30, 2007 Dear Committee Members, Many of you have participated by email and teleconferences and DTA board meetings to help make the first-ever Global Medical Device Conformity Assessment System (GeMDCAS) a reality. I also want to thank Courtney Emery more publicly for representing our committee at the recent DTA Board Meeting in Chicago. The financial support we received from the board was put to very good use this week. As we all know, sometimes it's simply the burden of travel that makes all the difference. There were more than one hundred guests from all over the world representing the IAF at the San Francisco meeting and I believe they will certainly not easily forget the DTA. DTA Wins IAF Support to Form New IAF Working Group for ISO 13485 "GeMDCAS" As the subject heading indicates, the IAF approved the formation of the new Working Group for ISO 13485. The DTA presentation to the IAF was very well received and immediately following the vote, Accreditation Bodies (ABs) in attendance were asked if they wanted to participate. Just as quickly, Accreditation Bodies from Japan, Canada, Australia, Singapore, Europe and the United States raised their hands. The response was overwhelming. One person stood up and indicated we needed to give the presentation to the World Health Organization. Needless to say, we not only got a lot of votes, we have a lot of active participation. Because of our leadership on this program, the DTA has been appointed by the IAF executive committee to lead the IAF ISO 13485 GMDCAS Working Group. GHTF Partnership? As you may also know, the WTO/WHO sponsored Global Harmonization Task Force (GHTF) is asking for the IAF to make a formal proposal to them regarding how we believe our new Working Group should work together with GHTF. I had already been discussing this with Paul Brooks of BSI and Harvey Rudolph of UL (who have also joined in our IAF working group). As the GHTF request came directly from the GHTF Steering Committee Chair, Dr. Larry Kessler of FDA, this is a significant development in our program's recognition. I plan to submit a proposal to the GHTF under the IAF letterhead before the end of next week. It will be signed by an IAF Executive Committee member on our behalf. Standards Development While at the IAF meeting, I had an opportunity to participate as a guest in TC 176 concerning development of the new ISO 9001:2009. I know that many of you are also ISO 9001 certified. I told them not to change anything. Industry hates changes to the QMS unless it's obvious that it is needed. They accepted my comments better than I had expected. They were concerned that people will wonder what TC 176 has been doing for the last nine years if the standard doesn't change. But the chair of TC-176 was willing to accept that, since industry is THEIR customer and they need to "satisfy" us. THANKS to JEFF AND KEITH - AGAIN!! I was reminded during the TC-176 meeting that standards development is tedious, thankless and costly work. I was also reminded how much we owe our thanks to Jeff Zawada (A-Dec) and Keith Dunn (Hu-Friedy), who continue to represent the US dental industry in developing dental product standards. Keith and Jeff have no doubt spared us hardships that we'll never know, just because they were there to prevent adverse statements being added to standards you may currently be using. Jeff Zawada also recently met with the ADA dental standards committee to explore how the DTA can best cooperate in standards development and use. I look forward to his report. Thank you all for your active participation and support! Grant Ramaley Chairman Regulatory Affairs and Standards Committee Dental Trade Alliance |
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