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  2. Risk Evaluation and Mitigation Strategies - Wikipedia

    en.wikipedia.org/wiki/Risk_Evaluation_and...

    Risk Evaluation and Mitigation Strategies (REMS) is a program of the US Food and Drug Administration for the monitoring of medications with a high potential for serious adverse effects. REMS applies only to specific prescription drugs, but can apply to brand name or generic drugs. [1] The REMS program was formalized in 2007.

  3. IEC 61355 - Wikipedia

    en.wikipedia.org/wiki/IEC_61355

    The main application is the construction, erection and operation of industrial plants where the number of documents of all engineering disciplines may sum up to some 100,000 documents. During 2024, the new cross-standard ISO / IEC 81355 [ 2 ] will be published and will replace the second edition of IEC 61355-1 published in 2008.

  4. Conformance testing - Wikipedia

    en.wikipedia.org/wiki/Conformance_testing

    Conformance testing is applied in various industries where a product or service must meet specific quality and/or regulatory standards. This includes areas such as: [1] [3] [4] [7] [8] biocompatibility proofing; data and communications protocol engineering; document engineering; electronic and electrical engineering; medical procedure proofing

  5. Submittals (construction) - Wikipedia

    en.wikipedia.org/wiki/Submittals_(construction)

    The construction documents, specifically the technical specifications, require the contractor to submit product data, samples, and shop drawings to the architect and engineer for approval. This is one of the first steps that is taken by the contractor after execution of the construction contract and issuance of the "Notice to Proceed".

  6. Specification (technical standard) - Wikipedia

    en.wikipedia.org/wiki/Specification_(technical...

    Specifications in North America form part of the contract documents that accompany and govern the drawings for construction of building and infrastructure projects. Specifications describe the quality and performance of building materials, using code citations and published standards, whereas the drawings or building information model (BIM ...

  7. Category:Construction documents - Wikipedia

    en.wikipedia.org/.../Category:Construction_documents

    Technical drawing (7 C, 67 P) Pages in category "Construction documents" The following 24 pages are in this category, out of 24 total.

  8. Type approval - Wikipedia

    en.wikipedia.org/wiki/Type_approval

    A CoC is a producer's declaration that equipment, e.g. a car or motorcycles comply with the given approved type. This document contains information about the equipment and its producer's identification, type approval number, other technical specifications. The content of a CoC is defined by the European regulation (Amendment IX, Regulation 92/53).

  9. CE marking - Wikipedia

    en.wikipedia.org/wiki/CE_marking

    Stage 5: Compile the technical documentation Technical documentation, usually referred to as the technical file, relating to the product or range of products needs to be compiled. This information should cover every aspect relating to conformity and is likely to include details of the design, development and manufacture of the product.