ISO 14971 third edition is released in December 2019 which cancels and replaces ISO 14971 second edition. Overall, there is not much change has occurred as the risk management process itself remains largely unchanged. However , there are important clarifications and updates in ISO 14971:2019 which are as below. Similarly ISO TR 24971 second edition Read more about New & changed Elements in ISO 14971:2019 Release – 3rd edition[…]
Prerequisites: ISO 62304:Quality Management System (QMS) – ISO 13485 Risk management – ISO 14971 IEC 62304: Software safety classification Software development process Software management process Software configuration management process. Software problem resolution process Medical Device Standards in One Frame
It is a common strategy for Medical device Manufacturers to outsource the manufacturing and services function to low cost destinations. But with the benefit of low cost also comes lots of problems related to regulations and management. As the supply chain becomes longer and more diverse and now with COVID-19 situation many disruptions getting surfaced, Read more about Medical Device Supply Chain – Managing the long chain as per FDA regulations[…]
To ensure that good quality assurance practices are used for the design of medical devices and that they are consistent with quality system requirements worldwide, the Food and Drug Administration revised the Current Good Manufacturing Practice (CGMP) requirements by incorporating them into the Quality System Regulation, 21 CFR Part 820. An important component of the Read more about Guidance document on the management of design and process changes[…]
As per GHTF find below the guide to know the definitions of Definitions of the Terms Manufacturer, Authorised Representative, Distributor and Importer. 1.1 Manufacturer “Manufacturer” means any natural or legal person with responsibility for design and/or manufacture of a medical device with the intention of making the medical device available for use, under his name; Read more about Definitions – Med Device Manufacturer, Authorised Representative, Distributor and Importer?[…]
UDI stands for a unique serial number given to each medical device. In this scenario, each identical device would be assigned its own serial number which becomes easy to track it through out its life cycle. To understand UDI you must also understand what it is not! . A good scope statement has both inclusion Read more about Unique Device Identification[…]
IEC- The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising all national electrotechnical committees (IEC National Committees). The object of IEC is to promote international co-operation on all questions concerning standardization in the electrical and electronic fields. FDA has approved IEC 62304 as recognized software development standard, allowing submissions stipulating conformance to Read more about Compliance With FDA/IEC Software Standard 62304[…]
The initial ISO 14971 had 9 clauses, but later recently in Dec 2019 it is changed and now contains 10 clauses i.e 1 more clause is added. to view the new changed standard elements click below New and Changed Elements of ISO 14971:2019 Release – 3rd Edition Old ISO 14971 Clauses Clause -1 – Scope Read more about Overview of ISO 14971[…]
Design Validaiton is a requirement of regulators prior to placing a product on the market. It is considered the last step of the Design Control process prior to transfer of the design to manufacturing. However, it is intimately tied to Process Validation a portion of Production Controls. Companies must assure that they are properly conducting Read more about What is design validation and what are rules applied[…]
This guideline is intended to help in applying current good manufacturing practice (CGMP) required under section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) in the manufacture of most investigational new drugs (IND) used in phase I clinical trials. This guidance describes an approach to •Implementation of manufacturing controls that are appropriate Read more about CGMP guidance for Phase I Investigational Drugs[…]