Regulatory Agencies
It is Japan’s regulatory authority responsible for the evaluation and approval of pharmaceuticals, medical devices, and regenerative medical products.
What is PMDA?
This is the testing and certification organization used by Cook to maintain our ISO certification.
What is TÜV SÜD?
The framework for Cook's Quality Management System can be found in this document.
What is the Cook Incorporated Quality Manual (CIQM)?
This colleague is the queen of change orders.
Who is Sarah?
Most of FDA's medical device regulations are in this CFR Title.
What is Title 21?
This is the regulatory audit program that allows a medical device manufacturer to undergo a single audit to satisfy multiple regulatory authorities.
What is MDSAP?
The purpose of this procedure is to describe the process Regulatory Affairs uses to support the preparation of regulatory submissions and the management of the databases that support these submissions for the global markets of Cook Incorporated.
What is RA Operations?
This colleague is Randy's fiercest rival when playing games.
Who is Maria?
Is the regulatory authority in the Kingdom of Saudi Arabia responsible for overseeing the safety, effectiveness, and quality of food, drugs, medical devices, cosmetics, and pesticides.
What is SFDA?
This is the ISO certification used by organizations involved in the manufacturing of medical devices.
What is ISO 13485?
The purpose of this is to collect and analyze information in order to identify, investigate, and determine the cause of nonconforming products and quality problems
What is Corrective and Preventive Action (CAPA)?
This team’s presentation is inspired by the Olympics theme.
Who is US/CA/ENG or Product Side/Sarah's team?
Is the National Health Surveillance Agency of Brazil.
What is ANVISA?
This standard specifies terminology, principles and a process for risk management of medical devices, including software as a medical device and in vitro diagnostic medical devices.
What is ISO 14971?
The purpose of this procedure is to describe Cook Incorporated’s methods, roles and responsibilities for the collection, assessment, implementation, and documentation of regulatory updates.
What is Regulatory Intelligence?
This colleague is an avid golf enthusiast.
Who is Aaron?
Is the regulatory agency for the United Kingdom overseeing medical devices, pharmaceuticals, and related healthcare products.
What is MHRA?
This international standard provides a framework for assessing the biocompatibility of medical devices to ensure that they are safe for use with human tissues.
What is ISO 10993?
The purpose of this procedure is to describe the actions which accompany considerations of the type that may impact customers’ regulatory requirements
What is Change Notification?
This colleague has been with Cook for XX years?
Who is Kris?