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Medical Devices - Regulatory Updates
Proactive strategies for Devices to minimize disruption
EU MDR Implementation Extension - helps in Compliance Planning
IVDR requirements for SOFTWARE
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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
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IVD Clinical Performance Studies for FDA & EU
Medical Devices - Regulatory Updates - June Volume 2
Medical Devices - Regulatory Updates - July Volume 1
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Registration for Labeling requirements/changes in COVID period
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IVDR : Clin evidence with Sensitivity & Specificity aspects
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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
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