February 2018 Blog Posts (21)

When a medical device fails to meet these standards for precision and accuracy

All medical devices have their stated intended use. With time, many of them undergo changes with use. Because of this, they need to be calibrated to retain their effectiveness. The FDA’s medical device calibration requirements have been devised with the same intention.

Although the FDA has medical device calibration requirements, many of these medical devices do not have specific measures that need to be set. So, in view of this, the FDA can only require that the…

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Added by Adam Fleming on February 27, 2018 at 4:58am — No Comments

FMEA in medical devices can work better when mated with ISO 14971

Failure Mode and Effects Analysis (FMEA) is a core aspect of risk management and risk analysis in medical devices. FMEA is essentially about analyzing the reasons for which a problem arises and the effects it has on the system. In the field of medical devices, it is absolutely critical to understand the failure mode and effects because the consequences of not doing this can be…

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Added by Adam Fleming on February 23, 2018 at 5:39am — No Comments

Florida capital to press for gun law change

A hundred Stoneman Douglas High School students are busing 400 miles to Florida’s capital Tuesday to urge lawmakers to act to prevent a repeat of the massacre that killed 17 students and faculty last week.

The students plan to hold a rally Wednesday in hopes that it will put pressure on the state’s Republican-controlled Legislature to consider a sweeping package of gun-control laws, something some GOP lawmakers said Monday they would consider. Shortly after the shooting, several…

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Added by Adam Fleming on February 20, 2018 at 5:02am — No Comments

Concerned about health and safety on the job?

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Added by John Robinson on February 20, 2018 at 4:55am — No Comments

Risk Management in the Global Economy and outlook for 2017

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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

An understanding of Risk Management and Analysis for Medical Device Manufacturers

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Added by John Robinson on February 16, 2018 at 5:29am — No Comments

FDA regulation on medical device packaging design

The FDA has regulations on medical device packaging design. This is quite natural, considering that the FDA has several regulations on all aspects of medical devices. However, it needs to be mentioned that the FDA regulation that covers medical device packaging design – Sec. 820.130 Device packaging under Subpart K–Labeling and Packaging Control -is a single liner, which only merely states that “each manufacturer shall ensure that…

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Added by Adam Fleming on February 16, 2018 at 4:46am — No Comments

Benefits of Risk Management in all Industries 2018

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Added by John Robinson on February 15, 2018 at 4:35am — 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

Ways of managing risk in construction projects

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The ways of managing risk in construction projects need to be drilled down into the systems that are used in construction projects. Managing risk in…

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Added by John Robinson on February 14, 2018 at 4:59am — No Comments

How is Risk Management Important to Project Success?

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The answer to how risk management is important to project success is best illustrated by the fact that no project has ever succeeded without proper risk…

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Added by John Robinson on February 13, 2018 at 5:06am — No Comments

Risk management methods and tools in the pharmaceutical and life sciences industries

Understanding and implementing risk management methods and tools is crucial for the pharmaceutical and life sciences industries in view of the fact that errors in this area can lead to dangers for human life. Since any mistake in any chain of in this industry can lead to serious consequences; the FDA and other regulatory…

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Added by John Robinson on February 12, 2018 at 5:09am — No Comments

It is important for organizations to validate their own Excel Spreadsheet Application

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Added by John Robinson on February 9, 2018 at 4:50am — No Comments

What is Emergency Planning and Community Right-to-Know Act (EPCRA)?

The Emergency Planning and Community Right-to-Know Act is a significant milestone in the detection and prevention of hazardous chemicals. The US Congress enacted this law in the wake of the Bhopal disaster in India. It seeks to involve…

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Added by John Robinson on February 8, 2018 at 5:03am — No Comments

OSHA’s standard on Respiratory Protection Safety Management Systems

Respiratory protection safety management system is a need for people who work in areas that require respiratory systems. Such people are exposed to various types of contamination, because of which they will be required to put on protective systems. The aim…

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Added by John Robinson on February 7, 2018 at 4:54am — No Comments

Medical Devices is aimed at ensuring very high quality assurance standards

Process validation for medical devices is a key ingredient of quality assurance in medical devices. Process validation is the criterion for measuring the effectiveness of a quality system for medical devices. The first step that medical device manufacturers have to take to show compliance with regulatory requirements for new and modified existing medical devices is obtaining premarket approvals (PMA) and premarket notifications. Process validation for medical devices is…

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Added by Adam Fleming on February 6, 2018 at 5:10am — No Comments

What is an Environmental Impact Statement?

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Added by John Robinson on February 6, 2018 at 5:03am — No Comments

What is Accounting Fraud and How to Prevent Financial Statement Fraud

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Key Takeaway: An understanding of what is accounting fraud and how to prevent financial statement fraud is an…

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Added by John Robinson on February 5, 2018 at 4:54am — No Comments

What is a Performance and Talent Management System?

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Added by John Robinson on February 2, 2018 at 5:22am — No Comments

CISOs map out their cybersecurity plan for 2018

When Omar F. Khawaja compiled his priority list for 2018, he didn’t include which security technologies he wanted or how many IT staff he hoped to hire.

Instead, the CISO at Highmark Health — a healthcare management and insurance provider whose portfolio includes Allegheny Health Network, United Concordia Dental and Visionworks, among others — articulated an overarching strategy on how the cybersecurity plan should fit within the national organization’s business…

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Added by Adam Fleming on February 2, 2018 at 5:05am — No Comments