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MDSAP Audit: Concepts, Plan and Requirements

Published on: October 2, 2024 by Naresh Bhakar

Medical Device Single Audit Program, in short form, is termed MDSAP. MDSAP enables the carrying out of one regulatory audit with respect to the quality management system of a medical device manufacturer. MDSAP is a process audit and product approval is still required which is country country-specific procedure. MDSAP has seven chapters and ninety tasks. … Read more

Documents Required for Class A Medical Device

Last Updated on: October 2, 2024 by Naresh Bhakar

Are you looking for the documents required for medical devices? If yes, in this article, you will find a list of those documents, which will be very useful in the future. Let’s discuss each document in detail. Here are the detailed Documents required for Class A medical device as per CDSCO. Application for grant of … Read more