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In the 1980s, the European Union began harmonising regulatory requirements. In 1989, Europe, Japan, and the United States began creating plans for harmonisation. The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) was created in April 1990 at a meeting in Brussels.
European Union: In the EU, Good Clinical Practice is backed and regulated by formal legislation contained in the Clinical Trial Regulation (Officially Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC). [3]
The World Dental Federation guidelines highlight that operators of dental radiography equipment must be sufficiently trained and qualified. When operating equipment, the staff member should be at least two metres away from the source, clear from the primary beam and behind a protective shield or wall where possible. [ 2 ]
Expanded duties dental assistants or expanded functions dental assistants, [49] as they are known in some states, may work one on one with the patient performing restorations after the doctor has removed decay [42] [43] Ideally, a dental assistant should have both administrative and clinical skills although it's still acceptable to have one or ...
A dental auxiliary is any oral health practitioner other than a dentist & dental hygienist, including the supporting team assisting in dental treatment. [1] [2] They include dental assistants (known as dental nurses in the United Kingdom and Ireland), dental therapists and oral health therapists, dental technologists, and orthodontic auxiliaries.
Continuing education or professional development is required in many fields, including teachers, insurance professionals, interior designers/interior architects, lighting designers, architects, engineers, emergency management professionals, school administrators, educators, nurses as well as those in the mental health professionals including ...
The Medical Device Directive—Council Directive 93/42/EEC of 14 June 1993 concerning medical devices—is intended to harmonise the laws relating to medical devices within the European Union.
ISO 13485 Medical devices -- Quality management systems -- Requirements for regulatory purposes is a voluntary standard, [1] published by International Organization for Standardization (ISO) for the first time in 1996, and contains a comprehensive quality management system for the design and manufacture of medical devices.
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