FDA指导文件-医疗设备中现成软件的使用Off-The-Shelf-Guidance_0.pdf,Contains Nonbinding Recommendations Off-The-Shelf Software Use in Medical Devices Guidance for Industry and Food and Drug Administration Staff Document issued on August 11, 2023. Document o
4.1.6SDIXshalldocumentproceduresforvalidationofcomputersoftwareusedintheQuality ManagementSystemasperValidationMasterPlanSOPG5807.Suchsoftwareapplicationsshall bevalidatedpriortoinitialuseand,asappropriate,afterchangestosuchsoftwareorapplication. Thespecificapproachandactivitiesassociatedwithsoftwarevalidationandrevalidationshall...
Section 5 Therapeutic Area Topics 治疗领域主题[译注:未翻译,有需要时单独查阅]Section 6 terminology 术语6.1 General 综述Common dictionaries should be used across all clinical studies and throughout the submission for each of the following: adverse events, concomitant medications, procedures, indications, ...
(as of the date of enactment of FSMA) to avoid unnecessary duplication of efforts and costs.3 On November 27, 2015, we finalized the implementing regulations establishing the framework, procedures, and requirements of the third-party certification program, including conflict of interest safeguards ...
To ensure patient safety, the Food and Drug Administration (FDA) and International Organization for Standardization (ISO) stipulate that medical device manufacturers establish and utilize a quality system to ensure products consistently meet regulatory requirements and applicable ISO 9001 and 13485standards....
Woodcock’s statement welcoming the opportunity for standardization, as it has the potential to bring cannabis further into the fold of standardized medicine. However, others in the industry have responded less positively, noting the potential for additional product analysis to drive up cos...
CDRH 与美国测试和材料协会(American Society of Testing and Materials,ASTM)、国际标准化组 织(International Organization for Standardization, ISO)一起,采用实验和计算固体力学的方法来研 究现有的和新材料相关的工程力学问题,以期为 FDA监管工作制订各类标准和指导文件。研究组考 察各类传统的工程材料(如金属和高...
Preparing for an Audit or Inspection Each audit or inspection will look slightly different than the last, however, at a high level, they follow similar procedures that allow for organizations to adequately prepare. For an ISO-related audit, the scope is different than a general inspection, and ...
The Agency believes "flexibility of the cGMP regulations should enable manufacturers to implement quality systems in forms that are appropriate for their specific operations." Therefore, they do not tell manufacturers how to write their procedures in order to compl...
Include an assessment of all test methods and procedures used by your firm to ensure they have appropriate instructions, method suitability criteria, and have been appropriately validated to determine whether they are fit for purpose. Based on this review, provide a detailed plan to remediate and ...