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MedTech Insights In Vitro Companion Diagnostics Regulations In
A Companion Diagnostic (CDx) is an in-vitro diagnostic (IVD) medical device that plays a critical role in personalized medicine treatment...
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CDSCO ComplianceMedTech Insights CDSCO Medical Device Approval Cost &
Central Drug Standard Control Organization (CDSCO) is the regulatory authority that regulates Medical Devices in India. It is important to...
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Pharmaceuticals Insights Computer Software Assurance(CSA) In Pharma &
Under 21 CFR part 11, it is required to validate the electronic systems that deal with electronic records and signatures....
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MedTech Insights In Vitro Diagnostics: Meaning, Types And
The term “in vitro” is a Latin word that means “in glass”. Thus, from a scientific approach, we can say...
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Regulations Digital Health In Regulatory Affairs
The old traditional methods of diagnosis, treatment and prevention have certain drawbacks such as late detection of non-symptomatic...
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Regulations What Is Structured Product Labeling (SPL)?
Structured Product Labeling format is used to submit the labeling content in electronic format. It is a standard...
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BiologicsRegulations Hong Kong: New Drugs, Generics, Biosimilars
Hong Kong- New Drugs, Generics, Biosimilar Regulations: Hong Kong has a robust regulatory system for pharmaceuticals, overseen by...
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Regulations Global Regulation of Cultivated Meat
Cultivated meat is changing the future of food. As the global population grows and meat demand rises, traditional...
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