Compliance Group

  What is Change Management? Change management is when an organization creates a step-by-step protocol to manage and implement modifications to products and processes. A change management plan is a protocol that implements and executes the change management processes in an organization to embrace and encounter changes in the workflows as defined. For example, any change in the existing product feature, new product implementation, process deviation, procedural update, or controlled documents requires a change management process. In a medical device company, changes are equipment modifications related to device design control methods, techniques, formulations, procedures, labeling, or associated documentation at an operational and manufacturing level. The required documents related to the change in supplier should be in place if there is a change in supplier or raw materials used. A change will lead to severe consequences if not handled properly. Changes can be permanent or temporary...

Medical devices, unlike prescription drugs, are reviewed by the United States (US) Food and Drug Administration (FDA) under one of two regulatory standards – Premarket approval (PMA), which requires clinical testing and inspections, or the 510(k) process, which does not. The second standard is intended for devices with a low or no risk of failure, as determined by the FDA. The medical device must be similar to a previously marketed device (predicate device). Introduction The FDA categorizes medical devices into one of three categories based on the level of control required to ensure the safety and effectiveness of the device and the level of risk the device poses to patients. Class I devices pose the least risk and are subject to minimal regulation — examples: tongue depressors, bandages, crutches, stethoscopes, and bandages. Class II devices pose a moderate risk and may be cleared through the 510(k) premarket notification process, which allows them to be marketed if they are substant...

Amid 2020, quality assurance leaders in the pharmaceutical, medical device, and other FDA-regulated industries highlighted compliance and production as part of their quality goals. Maintaining consistent compliance has remained part of the top three challenges the industry has been experiencing. How can firms in the life science industry overcome these challenges?   Software Quality Assurance   is the key industry trend and has many benefits in preventing mistakes to ensure compliance and patient safety. To summarize, software validation has been a requirement by the FDA since 1997. Software  Quality Assurance  (SQA )  is the set of activities that ensure processes, procedures as well as standards are suitable for the project and implemented correctly Furthermore, pharmaceutical and medical device companies may be one of the same. Today, many companies in the industry are still being audited and fined at high costs for similar but different compliant regulated i...