Regulatory Watch
Regulatory watch consists in the activity related to keep under active monitoring all the standards and regulation applicable to your…
Regulatory watch consists in the activity related to keep under active monitoring all the standards and regulation applicable to your…
ISO 18113 defines the requirements associated to labelling for In-Vitro Diagnostic Medical Devices. We have extensively discusse about labelling in…
There is no doubt about the central role of clinical evaluation in relation to the European Medical Device and in-vitro…
Hemocompatibility is on of the test requested to assess the safety of a medical devices that come in contact with…
4EasyReg provides trainings focused on the following topics: ISO 13485:2016 and 21 CFR 820 Quality Management System EU Medical Device…
The understanding and implementation of the regulatory requirements in the early stages of the product life cycle will ensure and…
The definition of harmonised standards (HS) is reported in a specific section of EU Medical Device Regulation 2017/745 and precisely…
ICH is the International Council for Harmonisation and deals with the harmanonization of technical requirements for pharmaceuticals for human use;…
Medical device containing substances or tissues derived from animals are important class of devices and they are highly regulated according…
The Information Security Management System Policy is one of the ket document for an efficient management of information security and…
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