Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)doi:EN ISO 13485:2016ISO 13485:2016规定了质量管理体系的要求,组织需要展示其提供持续满足客户和适用法规要求的医疗设备和相关服务的能力.这些组织可以参与生命周期的一个或多个阶段,包括设计和开发,生产,储存和...
The standard known as ISO 13485: 2003--Medical devices--quality management systems--Requirements for regulatory purposes, has become the global standard for... A Troschinetz 被引量: 0发表: 2010年 Risk Management in Medical Devices: An application of ISO 14971 (Medical devices – Quality managem...
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The section on drugs for human use describes how drugs are classified for regulatory purposes into new drugs investigative drugs antibiotics insulin and prescription and nonprescription drugs. All new drugs must be approved for safety and effectiveness by the FDA before they can be marketed imported ...
Regulatory Capital Requirements. (a) Each Banking Subsidiary shall at all times be at least "well capitalized" as defined in the Federal Deposit Insurance Corporation Improvement Act of 1991 and any r...
While the garment label requirements of different countries are similar in that these regulations are all in place for consumer protection purposes, there are some important differences between these requirements that you'll need to know about if you want to sell clothing or household textile items ...
Given that acknowledged cost, there has to be a clear gain to financial system soundness (the other limb of your statutory goals/purposes) from any new regulatory impost, but your document makes no effort to quantify such a gain (reduced probability of failure), or to demonstrate that tighter...
including centralized data sources (such as an enterprise data warehouse) as well as non-standard data sources (such as flat files or Excel files that augment enterprise data sources for reporting purposes). Finding where data sources are located, for purposes ofdata gatewayconnectivity, is importan...
Understanding UK consumer behaviour, competition, and regulatory requirements is crucial for success. Without thorough market research and a clear strategy, your business may struggle to gain traction. Adapting to the cultural and operational differences in the UK can also pose challenges, such as the...
(such as regulatory technical standards) adopted by the European Commission and any regulations, requirements, guidelines, rules, standards and policies relating to minimum requirements for own funds and eligible liabilities adopted by the Federal Republic of Germany or the Republic of Italy, a ...