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Medical Devices: The categories and the regulatory landscape
Medical devices encompass a wide range of products designed to diagnose, monitor, treat, or alleviate medical conditions. The regulatory landscape for medical devices varies globally…
Medical Devices License I MDL I MDEL
In Canada, Health Canada regulates medical devices, ensuring their safety, effectiveness, and quality. The primary legislation governing medical devices is the Medical Devices Regulations (MDR)…
Media Fill: A Critical Validation Process in Aseptic Manufacturing
What is Media Fill? A Media Fill, also known as a Process Simulation, is a critical microbiological validation technique used in aseptic manufacturing. This test…
Mastering Thermal Validation: A Comprehensive Guide for the Life Sciences Industry
What is Thermal Validation? Thermal validation ensures that temperature-controlled environments meet specified product safety, efficacy, and quality requirements. It involves measuring and documenting the thermal…
Master Calibration Schedules: The Key to Consistency in Drug Manufacturing
Maintaining precise and accurate measurements is critical to ensuring pharmaceutical products’ safety, efficacy, and quality in the pharmaceutical industry. The master calibration schedule is crucial…
ISO 13485: A Quality Management System for Medical Devices
ISO 13485 in Medical Device An ISO 13485 consultant is a qualified professional who can help medical device manufacturers implement and maintain an ISO 13485…
International Regulatory Framework (IRF): Navigating Global Standards
What is International Regulatory Framework (IRF)? The IRF or International Recognition Framework is a new initiative that aims to streamline the regulatory approval process for…
Internal Auditing: Significance and the Regulatory Expectations
Internal auditing is a crucial component of the pharmaceutical industry. It is responsible for ensuring compliance with regulations, maintaining product quality, and managing risks associated…
Integrating Artificial Intelligence into Commissioning Qualification and Validation (CQV)
Integrating Artificial Intelligence (AI) into Commissioning, Qualification, and Validation (CQV) practices in the life sciences industry Integrating Artificial Intelligence (AI) into Commissioning, Qualification, and Validation…
