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
Regulatory Strategy
Registrations & Dossiers
Authorized/Local Rep
UDI Consulting
CLINICAL
Trial Management
Clinical Operations & Monitoring
CEP/CER
PEP/PER
PMCF Plans & Execution
Technical
Biocompatibility & BERs
Risk Management
Usability
Labeling
Labeling
eIFU
Post Marketing
Safety & Vigilance
PMS
PSUR
EU MDR
IVDR
SaMD
Biopharma
Regulatory
Regulatory Strategy
Regulatory Intelligence
Submission Management
Publishing
CMC
Clinical / Non-clinical
Labeling
Life Cycle
Clinical
Central Monitoring
Late Phase Full service
CDM
Bio-Stat & SAS
Medical Writing
Automation
Automation
Regulatory Automation
Clinical Automation
Insights
About
About
About Us
Management
Certifications & Awards
Certified Quality
CSR
Career
Contact Us
Locations
Home
Insights
Insights
Are these findings observations in your CERs ?
1 March 2021
CER
Some companies finished their MED DEV R4 updates while some going through their NB reviews ...
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
Medical Devices – Regulatory Updates – February Volume 2
18 February 2021
Regulatory Updates
Europe | Thailand (FDA) EUROPE 1. Guidance on applying human factors to medical ...
Read More
Medical Devices – Regulatory Updates – January Volume 1
6 January 2021
Regulatory Updates
Europe | US FDA | CANADA (HC) | Australia (TGA) | China (CMDE) | India (CDSCO) EUROPE 1. ...
Read More
Medical Devices – Regulatory Updates December Volume 1
3 December 2020
Regulatory Updates
Europe | Australia (TGA) | Philippines (FDA) | China (CMDE) EUROPE 1. Converting ...
Read More
EU MDR Implementation Extension – helps in Compliance Planning
26 November 2020
EU MDR
As the extended transition deadline 26 May 2021 is approaching, we should be ready for ensuring ...
Read More
1
2
3
…
7
next »
The First Step
Let's talk about how MakroCare can help you
- Enquiry Type -
Business Enquiry/RFI/RFP
Partnership
Webinar
Career
Other
Submit
Contact Us