Notified Body Clause Samples
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Notified Body. In the European Union, is an entity that has been accredited by a Member State to assess whether a product to be placed on the market meets certain preordained standards. Process Validation – Establishing by objective evidence that a process consistently produces a result or product meeting its predetermined requirements [FDA 21 CFR Part 820]. Regulatory Requirement – all applicable domestic and foreign federal, state, and local laws, statutes, acts, ordinances, rules, codes, standards, guidelines and regulations, applicable to the “Supplier” and the “Product” provided under “Agreement” including but not limited to requirements for labeling, re-labeling, packaging, manufacturing, processing, assembly, record creation, record Title: Supplier Quality Agreement retention, record modification, record transmission (including by electronic means), storage, handling, and transport of “Product”.
Notified Body. A Conformity Assessment Body notified by the Notifying Authority as a notified Conformity Assessment Body in a specific field according to the applicable Gulf Technical Regulations.
Notified Body. The entity assigned by the designation authorities to undertake product conformity assessment activities under (EU) Regulation 2017/745. Auditing Organization (AO): An organization that audits a medical device manufacturer for conformity with quality management system requirements and other medical device regulatory requirements.