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Glossary

The glossary explains some important terms used in clinical research and clinical trials. In addition to our own knowledge and expertise, the following sources were used to define the terms:

  • Medical Device Regulation (MDR) 2017/745
  • Medical Device Directive (MDD; Richtlinie 93/42/EWG)
  • Medical Device Act (Medizinproduktegesetz; MPG)
  • MEDDEV 2.7/1 revision 4 (MEDical DEVices)
  • ISO 14155:2020
  • ICH-GCP
Search for glossary terms (regular expression allowed)
Term Main definition
conformity assessment
Conformity assessment means the process demonstrating whether the requirements of this Regulation relating to a device have been fulfilled.
contract research organization - CRO
A person or organization contracted by the sponsor to perform one or more of the sponsor's clinical investigation-related duties and functions.
coordinating (clinical) investigator
Clinical investigator who is appointed by the sponsor to coordinate work in a multicentre clinical investigation.
corrective action
Corrective action means action taken to eliminate the cause of a potential or actual non-conformity or other undesirable situation.
corrective and preventive action - CAPA
Corrective and preventive action (CAPA) is a process which investigates and solves problems, identifies causes, takes corrective action and prevents recurrence of the root causes.
custom-made device
A custom-made device is a medical device which is especially manufactured according to a written prescription and with specific design features and intended for the exclusive use of a patient designated by name. Mass-produced medical devices which need to be adapted to suit the specific requirements of the physician, dentist or other professional user, are not regarded as custom-made medical devices.