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Design and development files are essential documents in the medical device industry. They provide a detailed record of the design process, decisions, and validations that ensure a device meets regulatory requirements and is safe for use. Meeting the standards set by ISO 13485 and 21 CFR 820 is critical for manufacturers aiming to market medical devices in global markets, especially in the United States and countries recognizing ISO standards. This post explains how to create

What Is MDCG 2021-24 Rev.1? The MDCG 2021-24 Rev.1 is a guidance document published by the Medical Device Coordination Group (MDCG). It clarifies how to apply the classification rules set out in the MDR (EU) 2017/745. The document helps stakeholders determine the correct risk class for medical devices, which affects the regulatory pathway, including conformity assessment procedures. This guidance updates and refines earlier versions, addressing common questions and providing

The pharmaceutical industry in India operates under strict regulations to ensure the safety, quality, and efficacy of drugs and cosmetics. One critical part of this regulatory framework is Schedule M of the Drugs and Cosmetics Act. This schedule sets out the requirements for the manufacturing facilities of drugs, focusing on good manufacturing practices (GMP). Understanding Schedule M is essential for manufacturers, regulators, and stakeholders involved in drug production and