MedTech I.Q.

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November 2018 Blog Posts (8)

Will smart devices be the smartphones of the medical device industry?

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…

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Added by John Robinson on November 29, 2018 at 6:19am — No Comments

A Process Approach to Quality Management Systems

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…

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Added by John Robinson on November 26, 2018 at 7:38am — No Comments

Dramatic changes expected into medical device regulations

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…

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Added by Joseph Wilcox on November 22, 2018 at 6:37am — No Comments

How to Reduce Stress in the Work Place

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…

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Added by Roger Steven on November 21, 2018 at 7:18am — No Comments

FDA Scrutiny of Promotion and Advertising Practices

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…

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Added by John Robinson on November 20, 2018 at 7:38am — No Comments

Applied Statistics for FDA Process Validation

 

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…

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Added by John Robinson on November 19, 2018 at 7:34am — No Comments

How to Turn Your Cyber Incident Response (Plans from Blah) into Fantastic?

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…

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Added by Adam Fleming on November 16, 2018 at 7:02am — No Comments

Facts that Everyone Should [Know About] Fda Regulation

The Food and Drug Administration (FDA) is the US’ regulatory agency for a variety of products that concern the health of their consumers. The FDA regulates everything concerning food, medicine, medical devices, veterinary products and cosmetics, as well as products that emit radiation. In addition to directly regulating all these through its set of regulations, the FDA also encourages innovation in the products and processes of products in these…

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Added by Adam Fleming on November 2, 2018 at 6:30am — No Comments

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