Postmarket surveillance definition

Postmarket surveillance means the active, systematic, scientifically valid collection, analysis, and interpretation of data or other information about a marketed device.
Sample 1Sample 2Sample 3
Postmarket surveillance means the active, systematic, scientifically valid collection, analysis, and interpretation
Sample 1

Examples of Postmarket surveillance in a sentence

  • Postmarket surveillance of 3D-printed implants for sacroiliac joint fusion.

  • Postmarket surveillance: a review on key aspects and measures on the effective functioning in the context of the United Kingdom and Canada.

  • Law enforcement and surveillance: trail procedures and safeguards; Post-market surveillance; Sanctioning and other legal previsions and procedures.

  • Post-market surveillance report123.—(1) Manufacturers of Class I devices must prepare a post-market surveillance report summarising the results and conclusions of the analyses of the post-market surveillance data gathered as a result of the post-market surveillance plan referred to inregulation 122 together with a rationale and description of any preventive and corrective actions taken.(2) The report must be updated when necessary and made available to the Secretary of State upon request.

  • Post-market surveillance can take place by way of a review of manufacturer’s technical documentation sent in to the HPRA and/or by audit at the manufacturer’s premises.

  • Postmarket surveillance for medical devices: America's new strategy.

  • Post-market surveillance is a process used to ensure that equipment sold in the marketplace is consistent with equipment measured for compliance.

  • Issue 3 – Post-market surveillance and supportive data collection and analysisThe lifecycle of a medical device has traditionally been divided by regulators into two stages;pre-market and post-market.

  • Post-market surveillance activities conducted by Telecommunication Certification Body (TCB) in accordance with ISO/IEC Guide 65 and 47 CFR Section 2.962(g)(2).

  • Postmarket surveillance is not a substitute for obtaining the necessary premarket information to support 510(k) clearance, PMA, HDE, or PDP approval, or grant of de novo order.

Related to Postmarket surveillance

  • market surveillance means the activities carried out and measures taken by public authorities to ensure that products comply with the requirements set out in the relevant Union harmonisation legislation and do not endanger health, safety or any other aspect of public interest protection;

  • Surveillance means monitoring and observation of the disposal site for purposes of visual detection of need for maintenance, custodial care, evidence of intrusion, and compliance with other license and regulatory requirements.

  • market surveillance authority means an authority of a Member State responsible for carrying out market surveillance on its territory;

  • medical surveillance means a planned programme or periodic examination (which may include clinical examinations, biological monitoring or medical tests) of employees by an occupational health practitioner or, in prescribed cases, by an occupational medicine practitioner;

  • Police Department means the Police Department of the City and County of San Francisco.

  • Verified mail means any method of mailing that is offered by

  • Head of the Department means the administrative head of the department or the organization;

  • Department Chair means the chair of a department or the director of a centre or program.

  • Agencies means the Department, the Agency for International Develop- ment (AID), the International Commu- nication Agency (USICA), the Foreign Agricultural Service (FAS), and the Foreign Commercial Service (FCS).

  • Business reply mail envelope means an envelope that may be mailed free of

  • Monitoring Indicator means a measure of HSP performance that may be monitored against provincial results or provincial targets, but for which no Performance Target is set;

  • Regulatory Floodway means the channel of a river or other watercourse and the adjacent land areas that must be reserved in order to discharge the base flood without cumulatively increasing the water surface elevation more than a designated height.

  • District and high school graduation report means a report of the number of pupils, excluding adult education participants, in the district for the immediately preceding school year, adjusted for those pupils who have transferred into or out of the district or high school, who leave high school with a diploma or other credential of equal status.

  • PIR means Problem Identification Report.

  • Help Desk means the contact point established by Project Co in respect of the Help Desk Services for the notification of Demand Requisitions, the occurrence of Events and other matters arising in relation to the provision of Services;

  • BBB by Standard & Poor's or "Baa2" by Moody's, as promptly as practicabxx xxx in any case within 90 days of the event, the Master Servicer shall, at its expense, either

  • Generating Market Buyer means an Internal Market Buyer that is a Load Serving Entity that owns or has contractual rights to the output of generation resources capable of serving the Market Buyer’s load in the PJM Region, or of selling energy or related services in the PJM Interchange Energy Market or elsewhere. Generation Capacity Resource:

  • USDA means the United States Department of Agriculture.

  • Agency(ies) means any government regulatory authority or authorities in the world responsible for granting approval(s), clearance(s), qualification(s), license(s), or permit(s) for any aspect of the research, Development, manufacture, marketing, distribution, or sale of a Product. The term “Agency” includes, without limitation, the United States Food and Drug Administration (“FDA”).

  • Fire Department means an organized fire department as that term is defined in section 1 of the fire prevention code, 1941 PA 207, MCL 29.1.

  • Department sample means liquor that is placed in the possession of the

  • Maintenance Supervisor (Tradesperson) means an employee who has trade qualifications and has overall responsibility for maintenance at the place of employment and may be required to supervise other maintenance staff.

  • Telemarketing means any plan, program, or campaign which is conducted to induce the purchase of goods or services by use of one or more telephones, and which involves a telephone call, whether or not covered by the Telemarketing Sales Rule.

  • Research record means any data, document, computer file, computer diskette, or any other written or non-written account or object that reasonably may be expected to provide evidence or information regarding the proposed, conducted, or reported research that constitutes the subject of an allegation of research misconduct. A research record includes, but is not limited to, grant or contract applications, whether funded or unfunded; grant or contract progress and other reports; laboratory notebooks; notes; correspondence; videos; photographs; X-ray film; slides; biological materials; computer files and printouts; manuscripts and publications; equipment use logs; laboratory procurement records; animal facility records; human and animal subject protocols; consent forms; medical charts; and patient research files.

  • Nationwide Mortgage Licensing System and Registry means a mortgage licensing system developed and maintained by the conference of state bank supervisors and the American association of residential mortgage regulators for the licensing and registration of licensed mortgage loan originators.

  • Rebate Analyst means the person or firm selected by the Issuer to calculate the Rebate Amount, which person or firm shall either be a firm of attorneys or independent certified public accountants with expertise in the calculation of the Rebate Amount.