Publikasi

Biosafety Cabinets (BSCs): Types, Selection, and Best P...

Biosafety Cabinets (BSCs) are critical laboratory devices designed to provide a ...

Preparing Regulatory Strategy for Novel, New, and Next-...

In the fast-paced world of medical and in vitro diagnostic (IVD) devices, the de...

FDA Medical Device Classification: A Guide to US FDA 😷...

Medical devices are integral to modern healthcare, ranging from simple tools lik...

Understanding and Determining the Scope in a Quality Ma...

 This article explores the various definitions and contexts of "scope" in a Qual...

Types of Licenses Granted by CDSCO in Respect of the Ki...

The Central Drugs Standard Control Organization (CDSCO) serves as the National R...

FDA Evaluates Contaminants, Including Metals, in Tampon...

The U.S. Food and Drug Administration (FDA) has released findings from an indepe...

Impact of Change in Constitution of Firm on Your Licenses

Are you worried about the impact of a change in the constitution of your firm on...

The Call of India for Refurbished Medical Devices - CDS...

Refurbished medical devices are gaining traction in India as a cost-effective an...

Guidance on Loan License under D&C Act and Medical Devi...

A Loan License is a regulatory provision under the Drugs and Cosmetics Act, 1940...

The Regulatory Landscape and Future Outlook of Microflu...

Microfluidic diagnostic devices, also known as micro flow diagnostic devices, ha...

Standards and Certification: Identifying Certifiable & ...

In today's globalized and highly competitive world, standards play a crucial rol...

Usability Engineering in Medical Devices: Importance, R...

Over the past two decades, post-market surveillance has revealed concerning tren...

FDA Regulatory Pathways for LNP(Lipid Nano Particle)-Ba...

Messenger RNA (mRNA)-based therapeutics have ushered in a new era of precision m...

Risk Priority Number (RPN): A Practical Guide to Risk A...

Risk management in medical devices is a structured process that identifies, asse...

Choosing Product Development Methodologies in Regulated...

Industries like medical devices, in vitro diagnostics (IVDs), pharmaceuticals, a...

Medical Device Assessment and Approval Methods – A Study

Objective: This study compares regulatory assessment and approval methods for...