Career
Contact Us
Select Language
English
Afrikaans
Albanian
Arabic
Armenian
Azerbaijani
Basque
Belarusian
Bulgarian
Catalan
Cebuano
Chinese (Simplified)
Chinese (Traditional)
Croatian
Czech
Danish
Dutch
Esperanto
Estonian
Filipino
Finnish
French
Galician
Georgian
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
BioPharma
Regulatory
Consulting
Operations
Sub Management
Publishing
Authoring
CMC
Clinical / Non-Clinical
Labeling
Life Cycle
Clinical
Late Phase
CDM
Biostats & SAS
Central Monitoring
Medical Writing
Real World Evidence
Devices
Regulatory
Labeling
eIFU SERVICES
Clinical
CER
PER
Investigations
PMCF
Data Solutions
PMS
Vigilance
PSUR
Technical
BioCompatibility
EU MDR
IVDR
SaMD
Life Cycle
Automation
Regulatory
Clinical
Blog
Medical Devices - Regulatory Updates
Proactive strategies for Devices to minimize disruption
EU MDR Implementation Extension - helps in Compliance Planning
IVDR requirements for SOFTWARE
FDA/EU/MHRA/TGA suggestions for ongoing clin studies
Real-World Approach in Collecting Clinical Data for MDR & IVDR
SSCP for Devices: Challenges and Approach
RAPS -2019 Regulatory Convergence
6 Best Practices to Sustain Regulatory Labeling Compliance
Deadline Extended for DMF Type III eCTD Submissions by FDA
ISO 14971:2019 –Updates & older Version Differences
Regulatory CMC Changes for Pharmaceutical Products
Use of Retrospective RWD for EU MDR Compliance
Post Market Surveillance Planning and Challenges under EU MDR
EUDAMED and EU Medical Device Nomenclature
Med Device PMCF: How to get right Sample size
Labeling findings from FDA and other Agencies audits summary
Effect of GDPR on Medical Devices in EU
Sensitivity & Specificity Summary with Example
IVD Clinical Performance Studies for FDA & EU
Medical Devices - Regulatory Updates - June Volume 2
Medical Devices - Regulatory Updates - July Volume 1
Medical Devices - Regulatory Updates - July Volume 2
For Med Device Companies , Why Resilience is more important now?
How companies Acquiring Heathcare solutions from SaMD resources
Medical Devices - Regulatory Updates - August Volume 1
Devices and Diagnostics: 439 Clinical Studies for COVID-19
Medical Devices - Regulatory Updates - August Volume 2
Medical Devices - Regulatory Updates September Volume 1
Medical Devices - Regulatory Updates September Volume 2
UDI : FDA versus EU with CND taking center stage than GMDN
Device Label Externalizing or Outsourcing. Is it for you?
PMS Planning and Challenges under EU MDR
Medical Devices - Regulatory Updates November Volume 2
Medical Devices - Regulatory Updates December Volume 1
Medical Devices - Regulatory Updates January Volume 1
About
About Us
Management
Certifications & Awards
Certified Quality
CSR
Career
Contact Us
Locations
Whitepaper
Registration for Labeling requirements/changes in COVID period
Registration for PMCF Data Quality Challenges & Best Practices
Registration for IVDR Performance Evaluation ROC in absence of Gold Standard
Registration for IVDR requirements for SOFTWARE
Registration for New updates in ISO 14971 2019
Registration for PSUR in EU MDR
Registration for IVDR – when Diagnostic Accuracy
IVDR : Clin evidence with Sensitivity & Specificity aspects
Registration Clinical Data for MDR IVDR
Registration For PMS Planning and Challenges under EU MDR
Registration For EU MDR Medical Device Labeling Changes Challenges
Registration For Med Devices PMS/PMCF When AE Reporting Is Low
Registration For EU MDR How Are You Covered On Nanomaterials New Requirements
Registration For Restricted Substances EU MDR
Registration for Use of Retrospective RWD for MDR Compliance
Registration for Devices Clinical Evidence gaps matter & how to close
Registration for Medical Device Standards FDA vs EU
Registration for Regulatory Framework of Software as Medical Device
Registration for IVD Clinical Performance Studies for FDA & EU
Registration for Benefit-Risk: Qualitative and Quantitative FDA/EU Approach & Frameworks
Registration for UDI : FDA versus EU with CND taking center stage than GMDN
Registration for Post-Market Clinical Follow-Up Studies for Medical Devices
Registration for IVDR: Clinical/Performance Documentation requirements
Registration for Post-Brexit UK legislation for Medical Devices
News
List of articles in category News
Title
MakroCare Best Biotech Award 2012 from U.S. Commerce.
MakroCare is ISO 14155 certified (Medical Devices)
DDi Products mEDC & mCoder Selected by TOP Pharma in Q1
**MakroCare received Best Biotech Award 2011 from U.S. Commerce
**First Drug Development Services company to achieve TRIPLE certification
MakroCare opens new office in London, UK
MakroCare, LSK Global sign alliance agreement
CommzDevice introduced for Medical Device firms
PACE division increased Site list by 30%
Medical Coding newer models
Page 4 of 10
1
2
3
4
...
6
7
8
9
10
Have Questions? Need Info/Quotes?
*
*
*
*
Email
*
*
PREV
NEXT
RESET
SUBMIT
Have Questions? Need Info/Quotes?
*
*
*
*
Email
*
*
PREV
NEXT
RESET
SUBMIT