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What is good clinical practice (GCP)?
Good clinical practice (GCP) GCP is an international quality standard that governments can transpose into regulations that decide how clinical
Good clinical practice (GCP) GCP is an international quality standard that governments can transpose into regulations that decide how clinical
Historically, medical device manufacturers have frequently used Failure Modes and Effects Analysis (FMEA) to identify possible failures in
The new AEMPS instruction on the procedure to obtain the manufacturing licence is a long-awaited document for medical device (MD) and in vitro
A typical consultation we receive at AKRN Scientific Consulting is related to the essential documents required for planning, conducting and closing
Placing medical devices (MD) and in vitro diagnostic medical devices (IVDs) on the market is not an easy and short path. It takes years until the
As a general obligation under the EU regulations, manufacturers pursuing to place medical devices into the EU market shall “establish, document,
Safety reporting is a crucial aspect of a successful clinical investigation for medical devices. In addition to the Good Clinical Practice (GCP),
Everyone involved in clinical research must follow Good Clinical Practice (GCP) as specified in ICH GCP and the international ISO standard 14155:2020,
Clinical investigations with medical devices should be performed by health care professionals with scientific and medical qualifications and
Checkout our selection of resources about medical devices and clinical writing.
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