AGENDA RELATED TO AMENDMENT OF MEDICAL DEVICES RULES (MDR), 2017 CONSIDERATION OF THE PROPOSAL TO AMEND SCHEDULE V (QUALITY MANAGEMENT SYSTEM FOR MEDICAL DEVICES AND VITRO DIAGNOSTIC MEDICAL DEVICES) OF MEDICAL DEVICE RULES, 2017 IN LINE WITH ISO 13485: 2016 The Board was apprised that, Schedule V of Medical Device Rules, 2017 deals with Quality […]
Minutes of 82nd DTAB Meeting held at DGHS Read More »
ISO 13485 VS ISO 9001 QMS (Quality Management System) is an organized method or process that wraps all characteristics of design, supplier management, risk management, and manufacturing. The QMS system is the most important part of any quality and agreement process. It is the regulatory requirement that FDA (Food and Drug Administration) and ISO auditors
Divergence and Significance between ISO 13485 Vs ISO 9001: 2015 Read More »
Introduction of Techniques SOPs for Medical Device: An SOP (Standard Operating Procedure) is a series of instructions designed to assist businesses in carrying out everyday tasks. It is a technique specific to your activities that must be followed appropriately and properly. SOPs are often the first questions answered during an inspection. SOPs are necessary in
Techniques for Writing SOPs for Medical Devices Read More »
Medical Device Risk Management and Design Controls: Issues Device Manufacturers Need to Know Medical device design and expansion processes in the context of risk management need careful inspection and planning by manufacturers. We inspect five key issues companies face when connecting design and development with risk management and, essentially, patient safety. Risk/Benefit analysis is required
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Safe Injection Syringes : There are many reasons to enhance the safety of administering injections, The price and chronic shortage of medical supplies force desperate measures, which include reuse of single-use injection equipment. Moreover, scientific studies reveal that administering injections is not only a risk for medical personnel but also for ancillary staff such as
Why follow safe injection syringes & standard? Read More »
Entering Greece market offers tremendous opportunities by medical device companies, but it is not without challenges.
Medical Device Registration in Greece Read More »
Whereas a draft of certain rules further to amend the Medical Devices Rules, 2017 was published as required under sub-section (1) of section 12 and sub-section (1) of section 33 of the Drugs and Cosmetics Act, 1940 (23 of 1940) vide notification of the Government of India in the Ministry of Health and Family Welfare (Department of Health and Family Welfare)
New notification by DCGI Read More »
Medical Device Single Audit Program (MDSAP) The International Medical Device Regulators Forum (IMDRF) perceives that a worldwide way to deal with examining and checking the manufacturing of medical devices could improve their security and oversight on a global scale. At its debut meeting in Singapore in 2012, the IMDRF recognized a work gathering to create
Are You Preparing for the Medical Device Single Audit Program (MDSAP) Audit Process? Read More »
Here is the blog for every IVD manufacturers to know about the IVD regulatory framework to improve the health and safety of patients and users.The utilization of the term \’in vitro\’, which in Latin signifies \’in glass\’, is an impression of the way that most by far of these tests were initially performed in a test tube.
Why IVD Regulation Framework Is Done Separately? Read More »
The ultimate guide for Ethiopia medical device registration by FMHCACA (Food, Medicine, and Health Care Administration and Control Authority). Learn more about the medical device and IVD\’s classification and approval process for Ethiopia.
Ethiopia Medical device registration | Ethiopian Regulation Read More »
