- A global regulatory database focused especially on your needs as a regulatory professional in the medical device area?
- Updated on a daily basis? All documents organized thematically so they are easy to retrieve?
- A list of all newly published documents?
- Free-text search just like Google’s or Yahoo’s?
- And affordable?
Does this sound like a dream come true? Tarius new pre-defined product on Medical Devices is all that - and more! We have selected the relevant legislation, guidelines, forms, standards and other reference documents published by US and EU authorities as well as by several international bodies. Our primary focus is to help you avoid information overload by sorting out irrelevant information, as well as by increasing the relevancy and precision of search results, so you find the information you want - and only what you want - much faster.
What are the contents in Tarius Base Module: Medical Devices?
This online product is your ultimate resource for finding answers to global regulatory and quality questions related to medical devices. It provides, in one location, access to thousands of documents, including:
US Legislation: Relevant US Acts administered by the Food and Drug Administration.
US Code of Federal Regulations: 21 CFR parts 1-99 and 800-899, including Federal Register amendments (proposed rules and finalized rules)
FDA Reference Documents: All relevant guidelines from the FDA’s Center for Devices and Radiological Health (CDRH) concerning Classification, Clinical, In Vitro Diagnostics, Labeling, Quality, Submissions, Tracking and Reporting. In addition, the compilation includes MDUFMA and FDAMA Guidelines, FDA/ORA Compliance Policy Guides for Medical Devices, FDA Inspection Reference documents, FDA Forms and FDA Warning Letters and Notice of Violation Letters related to Medical Devices.
FDA Advisory Committees: Notice of meetings, agenda, panel roster, briefing information, summary, and other information from CDRH Advisory Committees public meetings.
US NIST: Guides to EU Medical Device directives.
US-EU Authorities’ Cooperation: Mutual recognition agreements, joint procedures, public statements, implementation plans, press releases, and more.
EU Regulations and Directives: All Regulations and Directives adopted by the European Council and the European Commission on medical devices.
EU Commission and EU Council Decisions, Communications and Guidelines: All "MedDev" documents on device classification, active implantable medical devices, in vitro diagnostic devices, CE marking, etc.
GHTF: All guidance documents published GHTF (Global Harmonization Task Force regarding Medical Devices) are included.
Eucomed: Position Papers published by the European Medical Devices organization.
ISO Standards: Bibliographic data to all ISO standards related to Medical Equipment in general (11.040.01) and Laboratory Medicine in general (11.100.01). This includes official abstracts and implementation status from European and US authorities. Information about drafts and updates to existing documents are also included.
What is included in the Annual Subscription Fee?
Included in your Annual Subscription Fee are a personal user ID and a password for access to the daily updated archive of information. Within the products, the following features are included in the annual fee:
- Global intelligence - search across US and EU regulations in one operation,
- Daily updates – new publications are automatically added to your subscription on a daily basis,
- Weekly email alert – sign up to receive news via email
- Clear indication of document status - whether "draft", "in force" or "superseded",
- Thematically organized – the detailed table of contents lets you navigate step by step,
- Highlighted search terms in documents - opening a document from the Search Hit List, search terms are automatically highlighted,
- Save your favourite search expressions – repeat targeted searches including also newly published documents to your search hit list,
- Personal bookmarks – speed up later retrieval of favourite documents,
- And more.