IHS Medical Devices Standards Collections - Offering You an Internet database of Compliance Standards relevant to the EU Medical Devices Directives The IHS Medical Devices Standards Collections were designed to ensure compliance to the European Union (EU) Directives that define the "essential requirements" (e.g., protection of health and safety) that goods must meet when they are placed on the EU market. It provides 24x7 access to vital industry standards from BSI, CEN, CENELEC, ETSI and other Standards Developing Organizations that are continually updated, and leverages sophisticated management tools to keep customers informed of standards critical to the design process. The collections contain the Directives and Harmonized Standards from the Official Journal of the European Union (EU) that supplement and interpret the requirements of the Directive. DSL Collections:
The IHS Medical Devices Standards Collections provide immediate access to the standards that are critical to the design control process. From engineering through production and quality assurance, you can have complete confidence in making the strategic business decisions that directly impact your costs, process efficiencies, time to market and product quality. Manufacturers that sell and distribute medical devices to the European Union (EU) must provide the presumption of conformity with the Directives’ essential requirements, and are subject to conformity assessment audits involving a Notified Body, e.g. TUV. All medical devices sold in the EU must have the CE Marking affixed to demonstrate compliance to the Medical Directives. It is essential for companies to have access to the harmonized European Standards that provide the presumption of conformity with the obligatory essential requirements of the EU Directives. The IHS Medical Devices Standards Collections provides access to a complete and always current standards solution – ensuring compliance to the European Union (EU) Directives: General (EU Directive 93/42/EEC), Active Implantable (EU Directive 90/385/EEC), In Vitro Diagnostic (EU Directive 98/79/EC), Electromagnetic Compatibility (EU Directive 89/336/EEC), and Low Voltage Equipment (EU Directive 73/23/EEC). The IHS Medical Devices Standards Collections enable subscribers to quickly search, view and print documents for archival or project reference, with confidence that it has the most up-to-date standards available. With IHS’ powerful search and navigation technology, customers can refine search results for pinpoint accuracy based on a variety of characteristics. The IHS Medical Devices Standards Collections offer complete indexing of related industry standards including full document viewing capability and access to the bibliographic records for nearly 1 million standards and military documents. This index includes document abstract outlines as well as full-text hyperlinks that cross-reference related documents. The IHS Medical Devices Standards Collections delivers to your desktop: Comprehensive Access – Contains the EU Directives and more than 1,200 Harmonized Standards from the Official Journal of the European Union that supplement/interpret the requirements of these Directives. With immediate and unlimited access to these standards from any workstation, subscribers can quickly search, view and print critical standards. Currency – Standards are updated daily; any revisions, amendments, supplements or errata will update automatically, so you always have access to the very latest information. Quality – Access to the IHS Medical Devices Standards Collections fulfills ISO document control requirements including revision tracking and updating. This helps to mitigate risks and increases productivity so that you can focus on what you do best – your business. Unlimited Access – You will get unlimited access to the most current standards in PDF format. Since it’s an annual subscription service, there aren’t discrete charges associated with each document. You won’t need to purchase duplicate sets of standards for every location in order to abide by Federal copyright laws. Multiple locations benefit by subscribing to a wide area network solution resulting in significant cost savings. The subscription service provides each location with immediate access to the index of standards. Document Lists – Allows you to quickly retrieve frequently needed documents, and you never again have to question whether your key documents are out of date. Document lists are easily created and can be customized for every user. Document Lists help you stay compliant with ISO and other quality standards by sending you email notifications when your selected documents are updated or revised. Ease and Convenience – Designed to be user-friendly for novice and expert users, our most popular search options are prominently displayed on the search screen. With IHS’ powerful search and navigation technology, you can refine search results for pinpoint accuracy based on a variety of characteristics. The IHS Medical Devices Standards Collections offer complete indexing of standards including full document viewing capabilities at your desktop. The index includes document abstract outlines as well as full-text hyperlinks that cross-reference related documents. Self-Administration – with the IHS Medical Devices Standards Collections, no gatekeeper or administrator is required. Users have access to the tools they need to do their jobs so there is no need to send multiple document requests across the organization. Online Access - Subscribers get secure online access to search, view, bookmark, track, and print documents according to the license agreement. Online documents are updated daily. Multiple users can share a single license. You also get access to IHS Standards bibliographic data – more than 1 Million documents. Individual Documents - IHS sell individual documents through the IHS Store in electronic or hard copy formats. Statistics show that 1 out of every 5 people who purchase individual documents would benefit from an online subscription. You should consider a collection over individual document purchases if your company buys more than $3,000 in standards per year.
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