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 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] 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: 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] 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 the hazardous situation. The harm is defined as a physical injury or damage to the health of a patient or of th...

Related to Legal 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 11.1 The Employer will develop and maintain an employee training and development plan and provide such plan to the Union upon request. Staff training is intended to provide an opportunity for classified staff employees for training sponsored by the University Training and Development and the UW Medical Centers Organizational Development and Training. Education/Professional Leave is intended to facilitate employee access to continuing education opportunities. Training and educational/professional leave may be used for the purpose of improving job performance, maintaining and increasing proficiency, preparing staff for greater responsibility, or increasing promotional opportunities within the framework of staff positions available at the University. 11.2 Any release time for training for employees accepted for such classes shall be in accordance with the Executive Order (currently No. 52) governing this matter. In the event that two or more employees request the same training period and supervision must limit the number of persons who may participate at one time due to work requirements, the selection will be made on a mutually agreeable basis within the department. 11.3 The training program is a proper subject for discussion by either departmental or University-wide Joint Union/Management Committees. 11.4 If the Employer requires an employee to receive training, reimbursement will be provided in accordance with the University travel rules. Employee attendance at Employer required training, either during or outside working hours, will be considered time worked and compensated in accordance with the provisions of this Agreement. 11.5 Employee attendance at training not required by the Employer and not covered by Executive Order 52, either on approved leave from or outside of working hours, will be voluntary and not considered time worked.

  • Professional Development and Training The Company shall pay for or reimburse the Executive for any reasonable professional development or training.

  • 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 1.1.1, 3.4.2, 3.11, 3.12.8, 4.2.8, 7.1.1, 7.1.2, 7.1.3, 7.3, 9.3.1.1 Construction Schedules, Contractor’s 3.10, 3.11, 3.12.1, 3.12.2, 6.1.3, 15.1.6.2

  • WORKING RULES B6.1 Subject to the terms of this Agreement, the Employer shall determine the number of employees required. B6.2 There shall be no inequitable minimum or maximum amount of work which an employee may be required to perform during the working day, and there shall be no restrictions imposed against the use of any type of machinery tools, or labour saving devices. B6.3 At the discretion of the Employer, employees may be changed from one classification to another within the jurisdiction of the Union provided that the employee is capable and qualified to perform the work. No employee's hourly rate shall be lowered during the shift under these provisions, and if an employee is assigned to work calling for a higher rate of pay he shall receive such higher rate of pay for the full shift. B6.4 Subject to the employee being capable and qualified to perform the work, no employee's hourly rate shall be lowered under these provisions, and if an employee is assigned to work calling for a higher rate of pay he shall receive such higher rate of pay for the full day. During emergencies, any employee of the Employer may be assigned to any work, provided, however, that no employee's hourly rate shall be lowered under this provision, and provided further that in the event an employee is assigned to work called for a higher rate of pay, he shall receive such higher rate for the full day. B6.5 The Employer shall make arrangements in each locality where employees are employed to enable such employees to cash their pay cheques or, where it is impracticable to do so, will provide any employee within twenty-four (24) hours written request with a cheque in the equivalent of subsistence allowance payable. Where camps are provided in remote areas devoid of normal banking facilities, the Employer shall make every reasonable effort to provide cheque cashing facilities, it being understood that where it is impracticable to do so, suitable substitute provisions shall be agreed at the Pre-job Conference. All cheques to be negotiable at par. B6.6 On jobs where camps are provided the Employer shall insure the personal effects of each employee against loss by fire in an amount not to exceed seven hundred fifty dollars ($750.00) provided an inventory of such personal effects is filed with the Employer. B6.7 The Employer shall provide gloves and coveralls to each employee who normally comes in contact with hot dope. In the event that an employee does not return the foregoing items supplied to him by the Employer, the Employer shall charge the cost of same to the employee and deduct this cost from any money owing to the employee.

  • CHANGE DIRECTIVE A Change Directive means a written instruction, which shall be deemed incorporated into and forming part of the Agreement, prepared by the Contract Administrator and signed by the Owner directing the Contractor to proceed with a change in the Work prior to or in the absence of the Owner and the Contractor agreeing upon adjustments in the Contract Price and the Contract Time.

  • Supervisor Within ten (10) business days from the occurrence of the matter on which a complaint is based, or within ten (10) business days from his/her knowledge of such occurrence, an employee shall file a formal written grievance. Three copies of the departmental grievance form shall be completed by the employee stating the nature of the grievance and the remedy requested from his/her departmental Management. The employee shall submit two copies to his/her immediate supervisor and retain the third copy.

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