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New Postings 

You should of been at the Meetings.....

Every April, AMDM hosts a week of meetings targeted directly at the IVD industry.  The response to this year's meeting was tremendous.  We had a great line-up of speakers that presented updates on all your compliance and submission issues.  Presentations from the 510K Workshop and Annual Meeting are now available on-line.  Remember to register in January for our 2010 meetings. More information is available on our Upcoming Meetings

Volunteers Needed
The Clinical Data Interchange Standards Consortium (CDISC) has formed a Device Sub-Team for proposing a domain for device properties/characteristics (Device Properties, DP) that is based upon the SDTM. The creation of this domain will permit diagnostic/medical device companies to begin submitting at least some device data to CDRH and CBER in a standard format. Many domains modeled in the SDTM Implementation Guide will become applicable to device trials.  The sub-team is seeking industry experts from the diagnostics industry (e.g., blood-screening assays), implantable devices (e.g., heart stents), and imaging, as well as FDA representatives from CDRH and CBER to be a part of this newly formed Device Sub-Team.  
Two levels of volunteer participation is needed:
1)  Participation in teleconferences every other week to help with proposing the new domains and completing other related work actions
2) Review the drafts created by the Device Sub-Team and provide feedback.
Individuals interested in getting involved in the development of new domains should contact Carey Smoak carey.smoak@roche.com  For more information, visit www.cdisc.org
Job Opportunity Postings

Regulatory, Quality, and Compliance personnel can find open positions within the industry by clicking on the "Job Opportunity" link to the left. 

Companies interested in posting open positions can send an e-mail request for information by selecting the "Contact Us" envelope to the left. 

Last updated: May 12, 2009 

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