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All Blog Posts Tagged 'medical' (159)

The ISO 13485: 2016

The ISO 134855

The ISO 13485, which is the ISO’s global medical device standard; was upgraded significantly in 2016. This upgrade was carried out primarily to help the standard keep up with the changes that have taken place in the industry in about the decade and a half since the previous standard was brought into effect in 2003.…

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Added by John Robinson on November 9, 2017 at 5:44am — No Comments

Complaints Handling, Adverse Event Reporting, and Recalls call for an integrated approach

Complaints Handling, Adverse Event Reporting, and Recalls4

Medical device manufacturers work and operate in various regulatory systems whose requirements are different and not always consistent with each other. The new ISO version, the ISO 13485:2016, recognizes…

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Added by John Robinson on October 24, 2017 at 6:54am — No Comments

Professionals Involved in The FDA’s Tougher Import Rules for 2017

Tougher Import Rules for FDA Imports in 2017

Of late, the FDA and the Customs and Border Patrol Service (CBP) have become increasingly agile, smart, sophisticated and demanding when it comes to the submission of information and adherence to government procedures from importing firms. The FDA and the CBP can delay, detain or refuse shipments of firms do not properly execute an…

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Added by John Robinson on October 23, 2017 at 6:24am — 1 Comment

Learn How to Prevent Quality and Compliance Problems by having a strong system for Purchasing Controls!

In this era of globalization; outsourcing has become a major component of business. Outsourcing brings many benefits for companies. Short and long-term cost benefits, the ability to concentrate on their core activities and grow their business, and the freedom of avoiding the actual tasks that go into manufacturing are some of the stated…

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Added by Adam Fleming on October 19, 2017 at 6:20am — No Comments

A step towards better health care

step towards Today, we live in an era of customization. Increasingly, customers can modify a product’s appearance, features, or content according to their unique needs or desires. Often, even the news we see in our newsfeeds is customized based off our preferences.

Why, then, are so many aspects of the health care industry still one-size-fits-all?

As doctors, we’ve seen firsthand how this can negatively impact patients who require more individualized care. One particular example…

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Added by John Robinson on October 19, 2017 at 6:02am — No Comments

Working with Physician Extenders to increase efficiency and profitability

A Physician Extender is one who is not a physician, but is of a lesser qualification, who helps physicians by carrying out many activities usually carried out by physicians. As the name suggests, Physician Extenders work to supplement the functions of a physician and could take a considerable load off her shoulders. In most cases, an advanced nurse practitioner or a physician assistant work as a Physician Extender.

A nurse practitioner is usually prepared and trained to impart the…

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Added by Roger Steven on October 18, 2017 at 6:46am — No Comments

Regulatory Filing Requirements and Compliance Processes for medical devices in Japan

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The market for medical devices in Japan is pretty huge. It ranks third in the world after the US and the EU. At just over $ 35 billion a year, which is characterized by an annual growth rate of 3-4 percent; it is far bigger than the markets in the neighborhood, such as China, Malaysia, Singapore and even Australia. Its market for medical devices is comparable to those of Europe and North America. Some of the reasons for this huge market are:

  • The aging…
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Added by John Robinson on October 12, 2017 at 6:24am — No Comments

Medical records retention and disposition is a complex activity

In a scenario where today’s healthcare environment is fast paced, diverse and straddle many disciplines; retention and disposition of medical records -both paper and electronic -is fraught with complexities. There are different rules set out by the state agencies, as well as by HIPAA statutes and regulations, for the way in which medical records need to be retained…

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Added by Roger Steven on October 11, 2017 at 7:12am — No Comments

What Should be Included in a Calibration Program

One of the very important activities for a laboratory is calibration. The terminology found in 21CFR160 (b) (4) spells out the requirements for this aspect of medical devices. In addition, other terminologies and concepts that need to be applied for an effective calibration program, but are not found in the regulation, such as instrument classifications, also need to be taken into consideration.…

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Added by Adam Fleming on October 9, 2017 at 6:16am — No Comments

15 ways to stay healthy in college

With crispy chicken strips and addictive fries at the Pilot House, nine seasons of The Office on Netflix and the newfound freedom of college, staying healthy and active at school can be more difficult than it was back home. Whether you’re a freshman or senior, it’s undeniable that healthy eating and self-care often takes the back burner when you have to juggle school, jobs and a social life.

Health-sayings-stay-happy-stay-healthy

Some freshmen even might worry about the…

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Added by Adam Fleming on October 3, 2017 at 6:39am — No Comments

Nitinol-based Medical Devices 2017 Global Market Expected to Grow at CAGR 10.50 % and Forecast to 2021

About Nitinol-based Medical Devices

Nitinol-based medical devices are made of nitinol, an alloy of nickel and titanium. The use of nitinol-based stents and guidewires has improved procedural outcome. The nitinol alloys are corrosion resistant and are highly accepted in the medical device industry. The global medical devices market has been growing extensively over the years. With increasing investment in research and development (R&D) for manufacturing…

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Added by Adam Fleming on September 19, 2017 at 6:05am — No Comments

Progress on global poverty and disease at risk, Gates says

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LONDON, Sept 13 (REUTERS) – Proposed United States budget cuts could put in jeopardy great progress in reducing global poverty and disease and lead to 5 million more deaths from AIDS alone, the philanthropist Bill Gates warned on Wednesday.

Gates, whose Bill and Melinda Gates…

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Added by John Robinson on September 13, 2017 at 6:38am — No Comments

The importance of meeting Supplier Management criteria

The importance of meeting Supplier Management criteria

Meeting the supplier management criteria set out by the FDA, the ISO and the QSR regulations is mandatory for the regulated industries. The qualification and assessment of suppliers is binding for the regulated industries. Being in compliance with the requirements for supplier management set out by the FDA and by the ISO…

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Added by John Robinson on September 11, 2017 at 6:18am — No Comments

Role of ‘technology’ in home health care

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At present, home-based health care is gaining significant traction and poised for transformation. Once recognized as a fragmented and unorganised sector, it is gaining ground through progressively capturing interest of entrepreneurs and investors.

It is a known fact that there is tremendous pressure on hospitals in delivering services at their facility, especially in Critical Care, something that can be easily outsourced…

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Added by John Robinson on September 8, 2017 at 6:14am — No Comments

Beyond the HIPAA Privacy Rule: Enhancing Privacy, Improving Health Through Research.

The Value and Importance of Health Information Privacy

Ethical health research and privacy protections both provide valuable benefits to society. Health research is vital to improving human health and health care. Protecting patients involved in research from harm and preserving their rights is essential to ethical…

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Added by John Robinson on September 1, 2017 at 5:42am — No Comments

Hipaa—Should I Be Worried?

This ongoing column is dedicated to providing information to our readers on managing legal risks associated with medical practice. We invite questions from our readers. The answers are provided by PRMS, Inc.  a manager of medical professional liability insurance programs with services that include risk management consultation, education and onsite risk management audits, and other resources…

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Added by John Robinson on September 1, 2017 at 5:41am — No Comments

Regulatory Compliance Webinars for just $10

Regulatory compliance webinars for just $10? You must be thinking: Oh, come on. Stop kidding. Tell me something believable. An offer such as this, where you get regulatory compliance webinars for just $10 may not be easily believable, but that doesn’t make it untrue! Yes, the extraordinary offer of regulatory compliance webinars for just $10 is on. And it is from GlobalCompliancePanel, a prominent provider of professional trainings for all the areas of regulatory…

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Added by John Robinson on August 31, 2017 at 6:56am — No Comments

Healthcare Compliance Professional Courses @ 10$ from GlobalCompliancePanel

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Healthcare professionals now have a stronger reason than ever before to enroll for professional learning courses and upgrade their knowledge. GlobalCompliancePanel, a highly reputable provider of professional trainings for all the areas of regulatory compliance, will offer a pick of their healthcare compliance courses for just $10.

Healthcare professionals…

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Added by John Robinson on August 11, 2017 at 8:12am — No Comments

Advocate General Opinion on Software Medical Devices

On 28 June 2017, Advocate General Sanchez-Bordona (AG) presented his …

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Added by John Robinson on August 10, 2017 at 8:38am — No Comments

Health Buzz: The 10 Best States for Health Care

 

Health Buzz The 10 Best States for Health Care If you want to get the best health care, you might be better off living in one of these states, according to a new ranking.

Hawaii, Iowa and Minnesota topped WalletHub’s new ranking of the best states for health care. The ranking took into…

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Added by John Robinson on August 8, 2017 at 5:48am — No Comments

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