Legal directives Sample Clauses

Legal directives. The principal applicable standard for CE certificated device is shown in Table 3: Table 3. Applicable CE Certificated Device Directives Standard Description IEC 60601-1 General requirements for safety – Collateral standard: Safety requirements and essential performance for medical electrical systems Beside this standard, a User Manual and a Manufacturing File shall be edited. Since a Bluetooth™ device will be embedded into the data logger, EMC (ElectroMagneticCompatibility) analysis will be carried out to the final device. Different tests are required to be performed as shown in :
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Legal directives. The principal applicable standard for CE certificated device is shown in Table 3: Table 3. Applicable CE Certificated Device Directives [45] Standard Description IEC 60601-1 General requirements for safety – Collateral standard: Safety requirements and essential performance for medical electrical systems Beside this standard, a User Manual and a Manufacturing File shall be edited. Since a Bluetooth™ device will be embedded into the data logger, EMC (ElectroMagneticCompatibility) analysis will be carried out to the final device. Different tests are required to be performed as shown in: Table 4. EMC tests and corresponding standards [46] Standard Test CISPR 11 RF emissions IEC 00000-0-0 Harmonic emission IEC 00000-0-0 Voltage fluctuation/ flicker emissions IEC 00000-0-0 Electrostatic discharge (ESD) IEC 00000-0-0 Electrical fast transient / burst IEC 00000-0-0 Surge IEC61000-4-11 Voltage dips, short interruption and voltage variations on power supply lines IEC 00000-0-0 Power frequency (50/60 Hz) magnetic field IEC 00000-0-0 Conducted RF IEC 00000-0-0 Radiated RF In the case of medical devices, the following directives are to be respected during the development and system validation, as shown in Table 5. Table 5. Applicable Medical Device Directives [15, 45, 46] Directives Description 93/42/EEC European Council Directive concerning medical devices 2007/47/EC2 Amendment of the European Council Directive 93/42/EEC concerning medical devices EN ISO 13485:2012 Medical devices QMS - Requirements for regulatory purposes EN ISO 14971:2012 Medical devices - Application of risk management to medical devices IEC 62366:2007 Medical devices – Application of usability engineering to medical devices IEC 62304:2006 Medical device softwareSoftware life cycle processes Particularly, note that in terms of software development of the sensors, risk management is carried out, guided by the standard IEC 62304:2006. An internal procedure of CSEM, responsible for development of sensors, is applied in the framework of the standard ISO 9001:2008. This procedure applies to all products designed and manufactured by CSEM that are qualified as medical devices or that might be used at a later stage as medical devices. This includes all devices that could be used in research project on human being and which are not considered as medical device. At CSEM, the risks are evaluated on the basis of the severity of harm, the probability of occurrence of the hazard and on the detectability of t...

Related to Legal directives

  • Directives all references in this Agreement to a Directive include any relevant implementing measure of each member state of the European Union which has implemented such Directive.

  • Compliance with Governmental Directives The DS Supplier also acknowledges and agrees that the Company may need to act in response to governmental or civil authority directives which may affect DS Load. The DS Supplier agrees to cooperate with the Company in order to comply with said directives.

  • Medical Director The Contractor shall employ the services of a Medical Director who is a licensed Indiana Health Care Provider (IHCP) provider board certified in family medicine or internal medicine. If the Medical Director is not board certified in family medicine, they shall be supported by a clinical team with experience in pediatrics, behavioral health, adult medicine and obstetrics/gynecology. The Medical Director shall be dedicated full-time to the Contractor’s Indiana Medicaid product lines. The Medical Director shall oversee the development and implementation of the Contractor’s disease management, case management and care management programs; oversee the development of the Contractor’s clinical practice guidelines; review any potential quality of care problems; oversee the Contractor’s clinical management program and programs that address special needs populations; oversee health screenings; serve as the Contractor’s medical professional interface with the Contractor’s primary medical providers (PMPs) and specialty providers; and direct the Quality Management and Utilization Management programs, including, but not limited to, monitoring, corrective actions and other quality management, utilization management or program integrity activities. The Medical Director, in close coordination with other key staff, is responsible for ensuring that the medical management and quality management components of the Contractor’s operations are in compliance with the terms of the Contract. The Medical Director shall work closely with the Pharmacy Director to ensure compliance with pharmacy-related responsibilities set forth in Section 3.4. The Medical Director shall attend all OMPP quality meetings, including the Quality Strategy Committee meetings. If the Medical Director is unable to attend an OMPP quality meeting, the Medical Director shall designate a representative to take his or her place. Notwithstanding the Medical Director ‘s sending of a representative, the Medical Director shall be responsible for knowing and taking appropriate action on all agenda and action items from all OMPP quality meetings.

  • PROCUREMENT ETHICS Contractor understands that a person who is interested in any way in the sale of any supplies, services, construction, or insurance to the State of Utah is violating the law if the person gives or offers to give any compensation, gratuity, contribution, loan, reward, or any promise thereof to any person acting as a procurement officer on behalf of the State of Utah, or who in any official capacity participates in the procurement of such supplies, services, construction, or insurance, whether it is given for their own use or for the use or benefit of any other person or organization.

  • Advance Directives When applicable, Provider shall comply with the advance directives requirements for hospitals, nursing facilities, providers of home and health care and personal care services, hospices, and HMOs as specified in 42 CFR Part 489, subpart I, 42 CFR § 417.436(d), 42 CFR § 422.128, and 42 CFR 438.3(i).

  • Training and Professional Development C. Maintain written program procedures covering these six (6) core activities. All procedures shall be consistent with the requirements of this Contract.

  • Professional Development and Training 4.1 The purpose of professional development and training requirements for interpreters is to maintain the skill levels interpreters possess at the time they pass their interpreter certification examination, and to further enhance their skills and knowledge. Both the State and the Union encourage interpreters to complete training and continuing education activities.

  • Legal and Regulatory Actions Contractor represents and warrants that it is not aware of and has received no notice of any court or governmental agency proceeding, investigation, or other action pending or threatened against Contractor or any of the individuals or entities included in numbered paragraph 1 of these Contract Affirmations within the five (5) calendar years immediately preceding execution of this Contract or the submission of any related Solicitation Response that would or could impair Contractor’s performance under this Contract, relate to the contracted or similar goods or services, or otherwise be relevant to System Agency’s consideration of entering into this Contract. If Contractor is unable to make the preceding representation and warranty, then Contractor instead represents and warrants that it has provided to System Agency a complete, detailed disclosure of any such court or governmental agency proceeding, investigation, or other action that would or could impair Contractor’s performance under this Contract, relate to the contracted or similar goods or services, or otherwise be relevant to System Agency’s consideration of entering into this Contract. In addition, Contractor acknowledges this is a continuing disclosure requirement. Contractor represents and warrants that Contractor shall notify System Agency in writing within five (5) business days of any changes to the representations or warranties in this clause and understands that failure to so timely update System Agency shall constitute breach of contract and may result in immediate contract termination.

  • Construction Change Directives 7.3.1 A Construction Change Directive is written order prepared by the Architect and signed by the Owner and Architect, directing a change in the Work and stating a proposed basis for adjustment, if any, in the Contract Sum, or Contract Time, or both. The Owner may by Construction Change Directive, without invalidating the Contract, order changes in the Work within the general scope of the Contract consisting of additions, deletions or other revisions, the Contract Sum and Contract Time being adjusting accordingly.

  • WORKING RULES B6.1 Subject to the terms of this Agreement, the Employer shall determine the number of employees required.

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