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Regulatory Auditing of Quality Systems of Medical Device Manufacturers

Whitepaper | Sep 29, 2017

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This document has been prepared by Study Group 4: Auditing which was convened by the Global Harmonisation Task Force. The members of this group were auditing experts from, or acting on behalf of, regulatory bodies and representatives of the medical device manufacturing industries from Australia, Canada, Europe, Japan and the USA. A list of the organisations represented on the Study Group can be found in Annex A. The incorporation of quality system requirements, based on ISO 9001/9002/9003, into regulations applicable to manufacturers of medical devices, provides the opportunity for developing mechanisms that would lead to global harmonisation.

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https://www.gerentllc.com/

Wipro Limited

Wipro Limited (NYSE: WIT, BSE: 507685, NSE: WIPRO) is a leading global information technology, consulting and business process services company. We harness the power of cognitive computing, hyper-automation, robotics, cloud, analytics and emerging technologies to help our clients adapt to the digital world and make them successful. A company recognized globally for its comprehensive portfolio of services, strong commitment to sustainability and good corporate citizenship, we have over 175,000 dedicated employees serving clients across six continents. Together, we discover ideas and connect the dots to build a better and a bold new future.

www.wipro.com

Co serve

Co serve is an Application Support provider in the regions of Indian sub-continent, South-East Asia and the Middle East. Compliance and regulation policies are ever-evolving in these regions. The objective of our alliance is to bring a robust EQMS solution built by quality experts and implemented and supported by local experienced technology consultants.

https://coservesolutions.com/

Atos

Atos provides a comprehensive suite of cloud and Salesforce-based solutions. This includes test automation, continuous integration, and development (CI/CD), DevOps automation, and automated support and monitoring driven by SyntBots®. This alliance was made to drive success for our mutual customers via reliable, scalable and cloud-native EQMS solution.

https://atos.net/en/

Mission of Love, Zambia

The mission is to empower the local church and village community to meet the great need of the many orphans and widows through the development of an orphanage. This mission is located deep in the heart of the bush of Zambia, 2 hours away from the closest small town called Kalomo.

Mission of Love, Zambia

Yogdaan Foundation, Nepal

Culture Through Compassion. An NGO that works selflessly to build shelters for earthquake victims in Nepal. Yogdaan endeavors to get disaster relief to areas that need it the most and that have been hit the hardest.

www.facebook.com/YogdaanNepal

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