David raino

David raino

Last seen: 2 months ago

Member since May 9, 2020 davidraino724@gmail.com

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Mental Health

FDA/EU/MHRA/TGA suggestions for ongoing clinical studies

There are several suggestions, recommendations from different health authorities for manufacturers to handle clinical trial aspects...

Dental Health

Global Regulatory eCTD and Submission Management Services

Global regulatory differences and constant changes to HA submission requirements even in the age of the Common Technical Do-ent...

Mental Health

in-vitro Diagnostic Regulation | MakroCare

Currently, only 10-20% of IVDs are subject to Notified Body scrutiny under the IVDD. That number will increase to 80-90% under the...

Health

Global CMC Regulatory Consulting Services

CMC (Chemistry Manufacturing and Controls) is at the core of most of MakroCare’s Regulatory activities. Over the years, CMC breadth...

Science

https://www.makrocare.com/blog/iso-14971-2019-updates-older-version-differences

ISO TR 24971 is the Technical Report on implementation of ISO 14971 and is not widely known or understood by industry ISO TC 210 and...

Services

6 Best Practices to Navigate and Sustain Regulatory Labeling...

It has always been a difficult task to be compliant with the changing regulatory norms. When it comes to labeling, the criticality...

Science

EU MDR implementation Extension

We all aware that the implementation date of Medical Device Regulations (EU) 2017/745 (EU MDR) been extended by one year (26 May 2021)...

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