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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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Regulations 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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AI TechnologyRegulations Regulatory Intelligence In Product Registration
Today ‘s age of AI has brought in tremendous success almost in every stream. Remarkably, AI has achieved...
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Regulations Top 11 Regulatory Information Management Software
Demand for regulatory information management software is growing due to increasing compliance requirements from health authorities, such as...
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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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