All Blog Posts Tagged 'Medical' (125)

Compliance for medical devices is a very broad and vast topic. When one talks of compliance for medical devices, one needs to keep in mind the various regulations that the FDA has put in place for manufacturers of medical devices to comply with. The FDA requires strict compliance with its laws and requirements because it is charged with the task of ensuring…

ISO 14971:2012 and IEC 62304:2006 are related but different global standards for risk management pertaining to software used in medical devices. Judicious application of these two standards is the way to go for medical device companies.

ISO 14971 and IEC 62304:2006 are global standards that govern risk management and lay out regulations and guidelines for…

Japan is the world's third largest market for medical devices, after the US and Europe. Ironically, many of the world's medical device manufacturers find language barriers for communicating with Japanese regulatory authorities a greater barrier than passing through the regulatory maze! The regulatory filing requirements for medical devices in Japan are…

A HIPAA audit is very important for service providing organizations, because the penalties for violations can bring their business down. It is important to understand the nuances of a HIPAA audit if one has to be successful.

A HIPAA audit is, for many service providing organizations, a make or break situation. This is because HIPAA audits are considered stringent. Violations can attract huge penalties, which is why getting it right the first time is extremely…

Nanotechnology, a part of Quantum Physics (QP), is growing fast and has myriad uses. Nanotechnology is all about size and self-assembly. While QP deals with subatomic particles and waves; Nano relates to the atomic and molecular level. Atomic behavior and properties get dramatically changed at the Nano level. Of note are properties such as color change due to refraction of light. Gold, packaging and chemistry are some of the well-known areas into which…

When HIPAA investigations relating to ransomware breaches find malpractices; it can be total jolt that can absolutely devastate the said practice or business. Discovery of this kind of breach during a HIPAA investigation can cause a major financial burden, apart of course, from severe embarrassment and ignominy.

This means that practices and businesses that are…

The combination of the implementation of new HIPAA regulations in the HIPAA Omnibus Update of 2013 and increased enforcement and audit activity has forced healthcare organizations to review their compliance and to ensure that they have the proper policies, procedures, and forms in place. Because of this, HIPAA Privacy Officers have been renewing their compliance activities and reviewing their documentation to make sure they can meet…

In a broad sense, GMPs refer to good manufacturing practices in any field. The main intention of these GMPs is that they enable industries to perform the required practices needed for complying with guidelines set out by the regulatory authorities. GMP guidelines are issued by regulatory authorities all around the world, mainly in the US, Canada, the countries of Europe and many others.

The ambit…

The emerging discipline of Hospitals Management Performance Assessments

Over the past few years, Hospitals Management Performance Assessments have begun to gain acceptability and credence in healthcare circles. Hospitals Management Performance Assessments came into being as a result of a conscious effort by advanced countries, mainly European, with sufficient backing from the World Health Organization (WHO) to arrive at some sort of metrics…

Medical Writing Services

After so much of trouble and difficulty to the physicians, researchers and healthcare companies to do healthcare composing at various points of your energy and effort, certain support companies have hit the market. Now you can meet any of your healthcare composing demand by just obtaining a support from these companies.

Writing on various healthcare professions is always…

Medical communication is the procedure for sharing medical education between pharmaceutical drug companies, physicians and other health professionals. It plays a vital role in raising awareness of medicines. Medical communication is essentially accomplished by medical communication agencies. Medical communications agencies are also called medical education agency or ‘MedComms’ firm.

WorkSureTM, a medical…

Leading pharmaceutical and biotech companies are increasingly under pressure to deliver effective new products in shorter time frames while minimizing the development costs. The structure, activities, resources of new product, planning regarding launch and successful commercialization of new product are main areas of focus of for medical affairs department in all the pharmaceutical companies. Many critical activities take place well in advance of the actual launch of a new…

The Medical affairs groups are a growing vital sector in today's bio pharmaceutical industry in providing hospital consultants, key opinion leaders (KOL's), regulatory agencies and healthcare professionals with scientific and medical information relating to the value and correct usage of the products.

Medical affairs personnel strive for the highest scientific integrity so as to produce…

New cells to replace those destroyed in diabetes type 1, cells to help heal a heart attack, cells to cure leukemia – this is the promise of stem cells. Some of this is happening now; more will be available in a few years.

Stem cells will usher in the era of regenerative medicine, allowing the creation of cells, tissues and organs to treat or cure diseases and injuries. This will be a fundamental alteration in our approach to medical care and a transformational medical megatrend. And…

Over the past ten years and since the publication of the Institute of Medicine landmark book “To Err Is Human” there have been many attempts to reduce preventable medical errors which are estimated to take about 100,000 lives per year – perhaps many more. The question is whether all of this effort has had a substantial clinical impact.

The results of a recently published study are therefore concerning. A…

1. Checklists Health care is catching on to something pilots have known for…