John Robinson's Blog – October 2017 Archive (38)

Complaints very strongly show a company how its products or services are perceived where it matters the most -in the customer’s mind. Complaint handling is one of the key indicators of how seriously a business takes its customers’ point of view. Complaints are to be expected from about any product; but their importance is all the more felt in an area like medical devices, because these products can affect the very life of…

The use of Applied Statistics for FDA Process Validation is considered a matter of very high importance in the pharmaceutical industry. The FDA’s guidance for the industry, which it called “Process Validation: General Principles and Practices”, was set up in 2011. This guideline sets the framework for Process Validation in the pharmaceutical industry. The FDA prescribes a three-stage process that any organization in the pharmaceutical industry has to set…

For many of us in the UK, the annual ritual of putting the clocks back for daylight saving time can be accompanied by a distinct feeling of winter blues as autumn well and truly beds in. This might be felt as a lack of energy, reduced enjoyment in activities and a need for more sleep than normal. But for…

A 31-year-old man who helped to repair homes in Galveston, Texas after flooding caused by Hurricane Harvey was recently diagnosed with flesh-eating bacteria and died on October 16th after being admitted to a hospital on October 10th, according to a statement released by health officials in Galveston on Monday.

He is the second person to die from…

Open heart surgery appears to be safer in the afternoon because of the body’s internal clock, scientists have said.

The body clock – or circadian rhythm – is the reason we want to sleep at night, but it also drives huge changes in the way our bodies work.

The research,…

As Republicans struggle to score a legislative win on taxes, Steve Forbes dismissed fears that the American economy is doomed to slow economic growth or secular stagnation as “preposterous.”

Forbes, the chairman and editor-in-chief of Forbes Media and former Republican presidential candidate, blamed the current economic rut on correctable policy errors in a lecture sponsored by the Cornell Republicans on Wednesday.

The real source of…

First class cabin passenger in Emirates Airline enjoying her dinner. Photo-Emirates

How does a global airline like Emirates cater to the needs of its over 55 million customers? Here’s a neat infographic that gives you a glimpse into how Dubai’s flagship airline is…

Kidneys are two bean-shaped organs located on the left and right side of the spine. They sit against the back muscles in the upper abdominal cavity. They are responsible for the extraction of waste from the blood, balancing body fluids, formation of urine, and facilitating other important functions of the body.

Kidney tumours are tumours (or growths) on or in a kidney and are also known as renal tumours. They can be benign (harmless) or malignant (leading to…

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…

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…

As Republican efforts to repeal and replace the Affordable Care Act continue in the background, some…

When you think of breast cancer, you think of a form of cancer that affects only women. It doesn’t.

While breast cancer in men is rare it’s still an issue for the 10 men on average who are diagnosed with it every year in Northern Ireland.

Ian Cranston, 70, was diagnosed with breast cancer in May. Two weeks later he had a mastectomy.

The Portadown father-of-two was given the all-clear in June…

The two most-common questions I hear when it comes to disposable dust masks/respirators are: “My employees wear disposable dust masks – do I have to fit test these employees?” and “How often should they change out their mask for a new one?”

First, it’s important to consider the masks themselves. These devices often are referred to as filtering facepieces and can be approved or unapproved. Unapproved dust masks can be mistaken for approved…