Tarius’ solution on medical devices (co-developed with GE Healthcare) covers the following elements for each of the 75+ countries, regions and international organizations:

 

1. National expert summaries, medical devices

Tarius national expert summaries are original documents written by Tarius’ national experts, providing updated information about the practical implementation of the international guidelines and “best practices” in a particular country. The summaries cover all major aspects of the product life cycle from product development to the post-marketing period.

 

 

 

 

Country by country, following the same table of contents and answering the same set of questions, Tarius national expert summaries give a general overview of the national procedures and requirements related to essential issues such as:

 

device classification, quality systems requirements, clinical trials, marketing approval/clearance applications, establishment registration, packaging and labeling, reporting, recalls (field actions), advertising and promotion, device tracking, inspection of manufacturing sites, sale to consumers, data protection, import/export, pricing and reimbursement, enforcement, and more.

 

In total, Tarius offers more than 20 national expert summaries per country.

 

All expert summaries include a reference section with direct links to the source documents from the national authorities. The national expert summaries are reviewed every month.

 

 

 

2. National authorities’ and international organizations’ documents

Working on a global basis involves monitoring information in numerous languages. Our editorial team of librarians and linguists is educated to work with the many different languages that are used by government authorities on national web sites. Every document in our database contains abstract, keywords and status information in English enabling Tarius users to identify important national documents even if they are unfamiliar with the language themselves.

 

 

 

 

Tarius routinely monitors national authorities’ websites and national official journals in order to provide all the relevant acts, regulations, directives, decisions, policy papers, guidelines, warning letters, enforcement documents, press releases, forms, and more. Newly published documents are uploaded to the web portal on a daily basis.

 

English metadata are added to each of the national documents (title, keywords, abstract, etc), enabling effective search in English – even if the original document is in non-English language. Previous and superseding versions are easily found via hyperlinks.

 

In addition, Tarius monitors a number of important international organizations’ websites, such as GHTF, Eucomed and ISO. Newly published information is added to our web portals on the day of publication.