Personal tools

Sponsorname

Your company could advertise here

www.fla-consulting.eu

Main Page: Difference between revisions

From GxPlex

Jump to: navigation, search
← Older editNewer edit →
No edit summary
Infobox header row, new nav + index queries
Line 1: Line 1:
This wiki is a structured reference database for regulatory documents in the medical devices, in vitro diagnostics, and pharmaceutical sectors. Each document is stored with standardized metadata (scope, validity status, region, official source) and linked to individual pages for its key articles, annexes, and provisions, organized by topic.
This wiki is a structured reference database for regulatory documents in the medical devices, in vitro diagnostics, and pharmaceutical sectors. Each document is stored with standardized metadata (scope, validity status, region, official source) and linked to individual reference pages for key articles, annexes, and provisions.


The database currently covers regulations, directives, and guidelines in the MD, IVD, GMP, PV, and NIS scopes. Cross-references between equivalent provisions in different regulations are maintained explicitly, for example between MDR and IVDR requirements on post-market surveillance or UDI.
The database currently covers regulations, directives, and guidelines in the MD, IVD, HM, GMP, PV, and NIS scopes. Cross-references between equivalent provisions in different regulations are maintained explicitly.


Structured queries are available on the [[Document_Index|Document Index]] and on each category page. Use [[Special:Ask|Special:Ask]] for custom queries across any combination of scope, status, region, or topic.
Structured queries are available on the [[Document_Index|Document Index]]. Use [[GxPlex_Search|GxPlex Search]] for filter-based browsing, or [[Special:Ask|Special:Ask]] for custom SMW queries.


All registered users can contribute. New pages require reviewer approval before becoming publicly visible. This is a test.
All registered users can contribute. New pages require reviewer approval before becoming publicly visible.


== Quick navigation ==
== Quick navigation ==
Line 12: Line 12:
|-
|-
| style="width:33%; vertical-align:top; padding:0 1em 1em 0;" |
| style="width:33%; vertical-align:top; padding:0 1em 1em 0;" |
=== By document ===
=== Browse ===
* [[Document_Index|All documents]]
* [[Document_Index|Document index]]
* [[GxPlex_Search|Search & filter]]
* [[Special:Ask|Custom SMW query]]
* [[Special:RecentChanges|Recent changes]]
* [[Special:RecentChanges|Recent changes]]
* [[Special:Ask|Custom query]]


| style="width:33%; vertical-align:top; padding:0 1em 1em 0;" |
| style="width:33%; vertical-align:top; padding:0 1em 1em 0;" |
=== By scope ===
=== By category ===
* [[:Category:Medical Devices|Medical Devices (MD)]]
* [[:Category:Medical Devices|Medical Devices]]
* [[:Category:In Vitro Diagnostics|In Vitro Diagnostics (IVD)]]
* [[:Category:In Vitro Diagnostics|In Vitro Diagnostics]]
 
| style="width:33%; vertical-align:top; padding:0 1em 1em 0;" |
=== By topic ===
* [[:Category:Clinical|Clinical]]
* [[:Category:Clinical|Clinical]]
* [[:Category:Post-Market Surveillance|Post-Market Surveillance]]
* [[:Category:Post-Market Surveillance|Post-Market Surveillance]]
* [[:Category:Labelling|Labelling]]
* [[:Category:Labelling|Labelling]]
* [[:Category:Traceability|Traceability]]
* [[:Category:Traceability|Traceability]]
| style="width:33%; vertical-align:top; padding:0 1em 1em 0;" |
=== Contribute ===
* [[Contribute_to_GxPlex|How to contribute]]
* [[Help:Adding_a_topic|Add a topic category]]
* [[Create_new_page|Create a new page]]
* [[GxPlex_Search|Find existing pages]]
|}
|}


== Current documents ==
== Recent documents ==


{{#ask: [[Status::Current]]
{{#ask: [[Document:+]]
| ?Document name = Name
| ?DocName = Document name
| ?Scope = Scope
| ?DocScopes = Scope
| ?Area of validity = Region
| ?DocValidityArea = Region
| ?DocStatus = Status
| format=table
| format=table
| headers=show
| headers=show
| limit=10
| limit=10
| sort=Scope
| sort=DocName
| order=asc
}}
}}


[[Document_Index|View all documents →]]
[[Document_Index|View all documents →]]

Revision as of 20:54, 27 June 2026

This wiki is a structured reference database for regulatory documents in the medical devices, in vitro diagnostics, and pharmaceutical sectors. Each document is stored with standardized metadata (scope, validity status, region, official source) and linked to individual reference pages for key articles, annexes, and provisions.

The database currently covers regulations, directives, and guidelines in the MD, IVD, HM, GMP, PV, and NIS scopes. Cross-references between equivalent provisions in different regulations are maintained explicitly.

Structured queries are available on the Document Index. Use GxPlex Search for filter-based browsing, or Special:Ask for custom SMW queries.

All registered users can contribute. New pages require reviewer approval before becoming publicly visible.

Quick navigation

Browse

By category

Contribute

Recent documents

 Document nameScopeRegionStatus
N.A. (STROBE)statement: guidelines for reporting observational studies Apr-2008(STROBE)statement: guidelines for reporting observational studiesINSN.A.N.A.
EU 2011/C 172/01 - CT-3 11-Jun-20112011/C 172/01 - CT-3GEUCurrent
USA 21 CFR Part 11 09-Apr-202521 CFR Part 11GUSACurrent
USA 21 CFR Part 312 09-Apr-202521 CFR Part 312HMUSACurrent
USA 21 CFR Part 314 09-Apr-202521 CFR Part 314HMUSACurrent
USA 21 CFR Part 320 09-Apr-202521 CFR Part 320HMUSACurrent
USA 21 CFR Part 50 09-Apr-202521 CFR Part 50GUSACurrent
USA 21 CFR Part 54 09-Apr-202521 CFR Part 54GUSACurrent
USA 21 CFR Part 56 09-Apr-202521 CFR Part 56GUSACurrent
USA 21 CFR Part 809 06-May-202421 CFR Part 809GUSACurrent
... further results

View all documents →

Rate this page
0.00
(0 votes)
Retrieved from "https://gxplex.org/index.php?title=Main_Page&oldid=6200"