All Blog Posts (1,642)

If you go "off label" with advertising and promotion, FDA's hammer can hit hard and seemingly out of the blue. Advertising and promotion for devices is weak and lacks legal clarity. For drugs, the regulations are prescriptive and guidance documents clamp down on nuances. Marketing and regulatory affairs departments must collaborate to avoid the hammer and penalties of FDA. The roadblock, however is that marketing managers and regulatory affairs managers rarely reach common ground and are…

The complexity and vulnerability of software is expanding exponentially, so fast that Congress removed some device software from FDA’s jurisdiction.  The remaining software regulated by FDA presents a degree of a risk to health that creates a public health concern.  Part of that risk involves the intentional activity that can conflict, intrude or destroy software.  The problems are taking center stage in the “healthcare software” dialogue.  What issues can compromise or defeat the…

FDA Commissioner, Scott Gottlieb, has announced a major overhaul of the FDA’s update to the Nutrition Facts label on products. This overhaul, the first in nearly twenty years, is aimed at empowering consumers by furnishing information on Nutrition Facts labels pure maple syrup and honey that ensures greater accuracy and is more science-based. With this, the FDA wants to help consumers make more informed and healthier choices.

This update to the Nutrition Facts label has incorporated…

One errant email or text message can cost you tens of thousands of dollars in HIPAA fines and penalties and it doesn't matter who you're communicating with: patients, staff, providers or with insurance carriers.

A violation is a violation. And if you think it couldn't happen to you, think again. Text and email HIPAA violations are not always caused by what you might think. For example, you may think you are safe as long as you don't text patients - you're wrong.…

Process Validation (PV), according to the FDA, is collecting and assessing data right from the design stage till the production stage. PV is set out for all the stages of production for a product in the FDA-regulated industries. The core purpose of PV is to establish scientific proof that any process being employed has the capability of delivering quality products consistently.

The FDA’s process validation requirements are set out in its general principles of Process Validation.…

If you work with data, you’re likely already familiar with common frustrations with Microsoft Excel like size limitations and manually entering data from multiple sources. Luckily there are two Microsoft tools- PowerPivot and PowerQuery-that solve ALL of these issues, right inside Excel.

In today’s world, there is tons of data to manage. Data is coming from many different sources. It is very important to be able to process that data quickly and then summarize it into meaningful…

How practice/business managers (or compliance offers) need to get their HIPAA house in order before the imminent audits occur. It will also address major changes under the Omnibus Rule and any other applicable updates for 2019.

The primary goal is to ensure everyone is well educated on what is myth and what is reality with this law, there is so much misleading information regarding the do's and don'ts with HIPAA - I want to add clarity for compliance officers and what you guys…

This is how the current-day situation of administering medical care runs: in the event of a medical need, the patient or someone attached to her is expected to sense the difficulty and call up the medical center to which the patient is attached. Help arrives after this is done. The medical practitioner may come over and attend to the patient at her location if the situation permits. Or else, the ambulance has to be called. All this has to done during what is called the Golden Hour: the most…

ISO 13485:2016 describes a process approach to Quality Management Systems for Medical Devices.  This 6 -hour virtual seminar will help you to understand the process approach and develop an effective Quality Management System (QMS) for Medical Device Companies.  A well-structured QMS meets the requirements of the Quality System Regulations and is both effective and efficient.  The regulations require that manufacturers “establish and maintain a quality system that is appropriate for the…

A slew of updates to existing medical device and diagnostics (MD & D) regulations is on the cards. Medical device and diagnostics is a field that keeps changing every now and then. But what is different this time is that the industry is up against a series of updates, not just from one regulatory agency, but from a multitude of agencies and standards: FDA, EMA, ISO 13485 and ISO 11607, the last of which is about packaging for terminally sterilized medical devices.

Nature of…

Workplace health and well being is a rising public health concern. Poor employee health can be costly to the organization (e.g. absenteeism, poor productivity, reduced attention and workplace safety).

Chronic stress has been shown to impinge decision-making, reduce concentration, immune system responses, and job satisfaction, cause psychological distress (e.g. depression and anxiety) and coronary heart disease, and negatively impact client rapport and personal…

If you go "off label" with advertising and promotion, FDA's hammer can hit hard and seemingly out of the blue. Advertising and promotion for devices is weak and lacks legal clarity. For drugs, the regulations are prescriptive and guidance documents clamp down on nuances. Marketing and regulatory affairs departments must collaborate to avoid the hammer and penalties of FDA. The roadblock, however is that marketing managers and regulatory affairs managers rarely reach common ground and are…

In Guidance for Industry Process Validation: General Principle and Practices, process validation is defined as, ""...the collection and evaluation of data, from the process design stage through commercial production.." The guidance further delineates the 'process design stage through commercial production' into three distinct stages of the product lifecycle:

Stage 1: Process Design: The commercial manufacturing process is defined during this…

Let us face it. A cyber incident could happen to any organization that has a computer system that is connected to the Net. Well, the next question is, does such an organization exist? Almost no organization in today’s world, no matter of what size and which part of the world it could be in, can function without a cyber system. So, this means that simply any organization is vulnerable to a cyberattack and every organization should have a cyber…

A medical device inspection. Ah! Is there a more dreaded exercise for a medical device manufacturer? If I were given a choice between taking up the world’s toughest rated examination and facing a medical device inspection, I would gladly opt for the former. A medical device inspection should rank right there ahead of the most difficult examination or task.

Alright. We knew this fact all along. So, why should I intimidate you by casting such aspersions on a medical device inspection?…

The Health Insurance Portability and Accountability Act of 1996 (HIPAA) is a US legislation that was enacted under the HITECH Act under Bill Clinton’s presidency with the intention of offering safeguards for medical information through its data privacy and security provisions. The Act consists of five sections. Also called titles, they are these:

• HIPAA Health Insurance Reform
• HIPAA Administrative Simplification
• HIPAA…

Trade and logistics, despite its relatively recent development, has gone on to become a global one. It is one of the many industries that have benefited in immeasurable ways by the growth of technology and globalization. It is no exaggeration to say that trade and logistics has exploded following these developments.

First, a basic understanding of the two:…

Microsoft Excel is a wonder package, and in saying this, I am not exaggerating or taking sides with Mr. Gates’s developers. They have created a program that is so versatile and so tailor-made for just so many industries that you would wonder from where they got the idea to do this. I reckon they must have worked extensively with the industry closely in understanding its needs and implemented all the details with devilish diligence.…