Essential Principles definition

Essential Principles means the Essential Principles of Safety and Performance of Medical Devices under GN-01.
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Essential Principles means the requirements relating to the safety and performance characteristics of medical devices and IVDs determined by the Council;
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Essential Principles means essential principles of safety and performance of medical device as described in these rules;
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Examples of Essential Principles in a sentence

  • Essential Principles of Safety and Performance of Medical Devices.

  • For example, a completed Essential Principles conformity checklist can be used to demonstrate that a recognized test standard was used as part of the method to demonstrate conformity to one Essential Principle.

  • A description of the materials of the device and their physical properties to the extent necessary to demonstrate conformity with the relevant Essential Principles.

  • Essential Principles for the Development of Reliability Standards NERC shall develop Reliability Standards in accordance with the NERC Standard Processes Manual, which is incorporated into these Rules of Procedure as Appendix 3A.

  • Essential Principles for the Development of Reliability Standards 6305.

  • The CSDT should identify the specific documents related to the method used to demonstrate conformity to the Essential Principles.

  • When the manufacturer uses international or other standards to demonstrate conformity with the Essential Principles, the CSDT should identify the full title of the standard, identifying numbers, date of the standard, and the organization that created the standard.

  • EXAMPLE: The completed Table of Conformity to the Essential Principles that a recognized test standard was used as part of the method to demonstrate conformity to one Essential Principle.

  • The device master file should contain the Clinical Evidence, Evaluation report that demonstrates conformity of the in vitro diagnostic medical device to the Essential Principles that apply to it.

  • The CSDT should identify the Essential Principles of Safety and Performance of Medical Devices that are applicable to the device.


More Definitions of Essential Principles

Essential Principles means Essential Principles of Safety and Performance of Medical Devices as described in the Technical Reference TR-004 Essential Principles of Safety and Performance of Medical Devices.
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Related to Essential Principles

  • MacBride Principles means those principles relating to nondiscrimination in employment and freedom of workplace opportunity which require employers doing business in Northern Ireland to:

  • the data protection principles means the principles set out in Part I of Schedule 1 to that Act, as read subject to Part II of that Schedule and to section 27(1) of that Act;

  • Principles means the document titled "Cruise Debt Holiday Principles" and dated 26 March 2020 in the form set out in Schedule 1.01(c) to this Agreement (as may be amended from time to time), and which sets out certain key principles and parameters relating to, amongst other things, the temporary suspension of repayments of principal in connection with certain qualifying Loan Agreements (as defined therein) and being applicable to Hermes-covered loan agreements such as this Agreement and more particularly the First Deferred Loans hereunder.

  • Certified nurse practitioner means an ARNP educated in the disciplines of nursing who has advanced knowledge of nursing, physical and psychosocial assessment, appropriate interventions, and management of health care, and who possesses evidence of current certification by a national professional nursing association approved by the board.

  • Mid-level practitioner means a certified nurse-midwife engaging in the independent practice of midwifery under the independent practice of midwifery act, an advanced practice registered nurse issued a license pursuant to K.S.A. 65-1131, and amendments thereto, who has authority to prescribe drugs pursuant to a written protocol with a responsible physician under K.S.A. 65-1130, and amendments thereto, or a physician assistant licensed under the physician assistant licensure act who has authority to prescribe drugs pursuant to a written agreement with a supervising physician under K.S.A. 65-28a08, and amendments thereto.

  • Nurse practitioner means an advanced practice registered nurse who is jointly licensed by the

  • Agreed Principles means the terms set out in Part 1 of Schedule 1;

  • essential requirements means all the conditions set out in Annex III which must be met by the rail system, the subsystems, and the interoperability constituents, including interfaces;

  • Privacy Shield Principles means the Privacy Shield Principles (as supplemented by the Supplemental Principles) contained in Annex II to the European Commission Decision C(2016)4176 of 12 July 2016 (as may be amended, superseded or replaced).

  • Participating Certified Nurse Practitioner means a Certified Nurse Practitioner who has a written agreement with the Claim Administrator or another Blue Cross and/or Blue Shield Plan to provide services to you at the time services are rendered.

  • Jurisprudence requirement means the assessment of an individual's knowledge of the laws and rules governing the practice of physical therapy in a state.

  • Non-Participating Certified Nurse Practitioner means a Certified Nurse Practitioner who does not have a written agreement with the Claim Administrator or another Blue Cross and/or Blue Shield Plan to provide services to you at the time services are rendered.

  • Halifax Abuse Principle means the principle explained in the CJEU Case C-255/02 Halifax and others;

  • general practitioner means a medical practitioner engaged in the provision of primary, continuing whole-patient care to individuals, families and their community not being a vocationally registered general practitioner.

  • Respiratory care practitioner means a person who is

  • Transparency Act means the Federal Funding Accountability and Transparency Act of 2006 (Public Law 109-282), as amended by §6202 of Public Law 110-252. The Transparency Act also is referred to as FFATA.

  • Cessation of practice means any calendar month during which respondent is

  • Volunteer worker means a person who is not your "employee", and who donates his or her work and acts at the direction of and within the scope of duties determined by you, and is not paid a fee, salary or other compensation by you or anyone else for their work performed for you.

  • Autism spectrum disorder means a neuro-developmental condition typically appearing in the first three years of life that significantly affects a person's ability to communicate, understand relationships and relate to others, and is frequently associated with unusual or stereotypical rituals or behaviours.

  • Chinese Medicine Practitioner means a Chinese medicine practitioner who is duly registered with the Chinese Medicine Council of Hong Kong pursuant to the Chinese Medicine Ordinance (Cap. 549) of the laws of Hong Kong, but excluding the Insured Person, the Policyholder, an insurance intermediary, an employer, employee, Immediate Family Member or business partner of the Policyholder and/or Insured Person.

  • collusive practices means a scheme or arrangement between two or more Bidders, with or without the knowledge of the Procuring Entity, designed to establish bid prices at artificial, non-competitive levels.

  • UK generally accepted accounting principles and practices means the principles and practices prevailing from time to time in the United Kingdom which are generally regarded as permissible or legitimate by the accountancy profession irrespective of the degree of use.

  • sole practitioner means an individual incorporated under the laws of the state of Iowa, or an individual in private practice who is providing substance abuse treatment services independent from a program that is required to be licensed in accordance with Iowa Code section 125.13(1).

  • Employment Practices Wrongful Act means any actual or alleged:

  • Information Privacy Principles means the information privacy principles set out in the Privacy and Data Protection Act 2014 (Vic).

  • Employment Practices means any wrongful or unfair dismissal, denial of natural justice, defamation, misleading representation or advertising, unfair contracts, harassment or discrimination (sexual or otherwise) in respect of employment by the Insured.