All Blog Posts Tagged 'Global' (15)

Risk Management in the Global Economy and outlook for 2017

Risk Management in the Global Economy and outlook for 2017.gif

Risk management in the global economy is a highly challenging field for risk managers from any part of the world. With most of the world’s countries almost…

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Added by John Robinson on February 19, 2018 at 4:34am — No Comments

Medical Device Process Validation is the Key Part of a Quality Process

Process validation is one of the essential functions of a quality system for medical devices. Medical device manufacturers who have to stay compliant with regulatory requirements have to obtain premarket approvals (PMA), as well as premarket notifications for both new and modified existing medical devices. The key to all these is medical device process validation.

The FDA…

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Added by Adam Fleming on February 14, 2018 at 5:04am — No Comments

Global Supply Chain Regulatory Compliance

Global supply chain regulatory compliance has become more important than ever before because of the confluence of a number of factors. As globalization becomes inevitable and inescapable, the global supply chain is one of the core arenas in which it plays out. The outgrowth brought about…

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Added by John Robinson on January 23, 2018 at 5:33am — No Comments

Best Practices in Vendor Risk and Compliance Management

Best Practices in Vendor Risk and Compliance Management.jpg https://globalcompliancepaneltraining.files.wordpress.com/2017/12/best-practices-in-vendor-risk-and-compliance-management.jpg?w=838 838w,…

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Added by John Robinson on December 13, 2017 at 4:45am — No Comments

Quality Risk Management in the FDA-Regulated Industry

Quality Risk Management in the FDA-Regulated Industry.jpg https://globalcompliancepaneltraining.files.wordpress.com/2017/12/quality-risk-management-in-the-fda-regulated-industry.jpg?w=874&h=490 874w,…

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Added by John Robinson on December 5, 2017 at 6:08am — No Comments

Export, Import and Trade Compliance Principle – an understanding

Export, import and trade compliance principle is a very important guiding standard for governing trade policies and ensuring compliance with the set national, regional and global trade norms. It helps to define an organization’s adherence to the export, import and trade compliance principle laid out by the government and also offers an…

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Added by John Robinson on December 4, 2017 at 4:50am — No Comments

What is logistics and supply chain management?

What is logistics and supply chain management

Logistics and supply chain management (SCM) constitute a very important element of businesses. Getting the logistics and supply chain management aspects right is necessary for the smooth flow of products from their source to destination, during the course of which many activities need to be performed.

Logistics and supply chain management is emerging as a…

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Added by John Robinson on November 29, 2017 at 4:53am — No Comments

What are the potential areas of risk management?

What are the potential areas of risk management.jpg The most critical aspect of risk management is the identification of potential areas of risk management. This helps the organization to stay focused on the areas in which it could possibly face risks, rather than taking an aimless view and shooting about in the dark.

In a very broad sense, the potential areas of risk management include all areas of a business, because simply…

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Added by John Robinson on November 23, 2017 at 4:41am — No Comments

Managing a medical device recall efficiently and effectively

A medical device recall means the correction or removal of a device for human use where FDA finds that there is a reasonable probability that the device would cause serious, adverse health consequences or death. It is an action taken to address a problem with a medical device that violates FDA law. Recalls are made when a) a medical device is defective; b) when it could be a risk to health, or c) when it is both defective and a risk to health.…

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Added by Adam Fleming on November 11, 2016 at 4:39am — No Comments

Diligence is Necessary for Postmarketing Vigilance Reporting for Medical Device Manufacturers

A few important postmarketing vigilance revisions are now being implemented. One of these is the revised medical device guidance document on postmarketing vigilance (MEDDEV 2.12-1 rev 5), which came into force on January 1, 2008.

Offering greater clarity and more guidance than the previous version, the new document includes new reporting terminology and many new concepts. It has also excised or added new, important terms.…

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Added by Adam Fleming on October 26, 2016 at 5:59am — No Comments

Device Establishment Registration and Listing in line with the FDA’s Proposed Rule

Annual registration is a requirement for any device firm, establishment or facility whose business relates to the production and distribution of medical devices intended for use in the US in some or another way.

Such business establishments have to register with the FDA and also need to list the devices that are made there and the activities that are performed on those devices.…

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Added by Adam Fleming on October 20, 2016 at 5:59am — No Comments

"Crisis Commons" ... Haiti Earthquake Relief - Open Source, Real-Time Networks, Info & Maps

Colleagues,

Thank you to MedTech-IQ members Michael Russel and Bart Stidham for informing me about CrisisCommons, host of CrisisCamp, at: http://www.crisiscommons.org/. Crisis Commons is an international volunteer network that creates open source tools for responders to mitigate disasters.

Crisis Commons includes:…

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Added by CC-Conrad Clyburn-MedForeSight on January 21, 2010 at 8:47am — No Comments

Telemedicine in Haiti ... A Humble Assessment of Where We Are

Colleagues,

First, I want to thank the many of you who have shared your thoughts on how emerging medical technologies - Telemedicine, mHealth, Distance Learning, ect.. - can be used to support the humanitarian relief efforts in Haiti. Clearly, this community has a great deal to offer.

As we all can see, the acute phase of the disaster relief response is still coalescing. Consequently, while conditions on the ground are improving, they are still chaotic. As in all major… Continue

Added by CC-Conrad Clyburn-MedForeSight on January 20, 2010 at 7:00pm — 2 Comments

New Member Update...2 March 2009

Colleagues,

Thanks to your efforts, the MedTechIQ community continues to grow and attract new members, along with their talents and collective experience. We are all, in the end, potential digital resources for each other.

Please remember ... one of the most useful ways to leverage the MedTechIQ network is to explore the "Search" boxes. They efficiently open up for you multi-media information resources and potential expert contacts. Both the universal search, in the upper… Continue

Added by CC-Conrad Clyburn-MedForeSight on March 2, 2009 at 3:30pm — No Comments

Institute of Med (IOM): U.S. Commitment to Global Health - Recommendations for New Administration

Colleagues,

As just released by IOM...GLOBAL HEALTH SHOULD BE KEY COMPONENT OF U.S. FOREIGN POLICY...The U.S. should significantly intensify its commitment to global health in the next four years by increasing funding and placing greater importance on health when setting overall U.S. foreign policy, says a new report from the Institute of Medicine written to inform the incoming administration's future policies. To achieve this level of commitment, a White House Interagency Committee… Continue

Added by CC-Conrad Clyburn-MedForeSight on December 17, 2008 at 5:59pm — No Comments