Select Language
Afrikaans
Albanian
Arabic
Armenian
Azerbaijani
Basque
Belarusian
Bulgarian
Catalan
Cebuano
Chinese (Simplified)
Chinese (Traditional)
Croatian
Czech
Danish
Dutch
English
Esperanto
Estonian
Filipino
Finnish
French
Galician
German
Greek
Haitian Creole
Hebrew
Hindi
Hungarian
Icelandic
Indonesian
Irish
Italian
Japanese
Korean
Latvian
Lithuanian
Macedonian
Malay
Maltese
Norwegian
Persian
Polish
Portuguese
Romanian
Russian
Serbian
Slovak
Slovenian
Spanish
Vietnamese
Welsh
Yiddish
Menu
Devices
Regulatory & QA
Strategy
Registrations & Dossiers
Authorized Rep
QMS Management
Audits
CLINICAL
CRO Full Service
Trial Management
Clinical Monitoring
CDM / Statistics
Writing & Scientific
CEP/CER
PEP/PER
PMCF / SSCP
Scientific Literature Services
Labeling Areas
Labeling
Design
UDI Consulting
eIFU
Post Marketing
Safety & Vigilance
PMS
Safety Reports
Technical
Biocompatibility & BERs
Risk Management
Usability
IVDR
Biopharma
Regulatory
Regulatory Strategy
Regulatory Intelligence
Submission Management
Publishing
Labeling
Life Cycle
cdisc SEND
Clinical
Study Management
Central Monitoring
Late Phase Full service
CDM
Biostat & SAS Programming
Writing
Medical
CMC
QA GCP Services
Clinical Quality Services
ConsumerHC
Regulatory
Regulatory Intelligence
Submissions
Labeling
Life Cycle
Writing / Reports
Clinical
CMC
Medical Communications
Insights
About
About
About Us
Management
Certifications & Awards
Certified Quality
CSR
Career
Contact Us
Locations
Home
Insights
Insights
eIFU for IVD: Country Specific Regulations and Benefits
18 April 2023
IVDR
There are several benefits of using electronic Instructions for Use (eIFU) labeling for medical ...
Read More
Trend reporting in IVDR context and Requirements
11 May 2022
IVDR
Introduction: Manufacturers of devices, made available on the Union market, ...
Read More
IVDR: Latest plan of action from MDCG
19 April 2022
IVDR
Set A – Essential ...
Read More
Is your Diagnostic State-of-Art? Are you sure & you think you can convince you NB?
24 February 2022
IVDR
You being "SURE", or your company thinks their Products have SOA does not help as it needs to be ...
Read More
MHRA: Registration requirements for IVDs
10 June 2021
IVDR
The UK Medicines and Healthcare products Regulatory Agency (MHRA) updated the guidance on ...
Read More
Is your Diagnostic State-of-Art?
1 March 2021
IVDR
Are you sure from IVDR perspective ? You being “SURE”, or your company thinks their ...
Read More