IMDRF was born in October 2011 (as the successor of the GHTF).
The current members are:
The World Health Organization (WHO) is an Official Observer.
GHTF was conceived in 1992 in an effort to achieve greater uniformity between national medical device regulatory systems.
GHTF was comprised of five Founding Members:
GTHF prepared a lot of helpful guidance documents -archived by IMDRF and still worth reading them - and stopped its activities in 2011.
On the AHWP website all final Documents are available for download.
The idea of the Medical device single audit program is to cover several jurisdictions in just one audit.
The program is run by IMDRF and currently covers the following countries quality system requirements:
Other countries are actively participating in the discussion and may lateran join the program.
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Auditing organisations under the MDSAP program are published on the FDA MDSAP Website and include:
Helpful guidance documents
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