All Blog Posts (1,471)

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…

Medical device reporting and recalls have enormous benefits for the medical device company and the public if implemented properly. They can prevent use of…

Though short in length,HIPAA Security Rule principles are well defined in some areas, but vague in some others, making implementation of these areas difficult.

HIPAA Security Rules are an offshoot of the Privacy Rule. While Privacy Rule concerns itself with Protected Health Information (PHI) in general, the HIPAA Security Rule (SR) concerns itself…

In order to ensure GMP compliance, pharmaceutical laboratories have to devise a holistic and long term plan that covers all aspects of the laboratory's activities.

Good Manufacturing Practices (GMP) requirements for laboratories have been set out by various regulatory bodies. The aim of GMP compliance for a pharmaceutical laboratory is to ensure…

Software Validation Process for 21 CFR Part 11 is all about authenticity and integrity of electronic signatures and records. Care should be taken to avoid confusion and get validation right.

The FDA’s Code of Federal Regulations (CFR) is a collection of laws that regulate the various government agencies. Different titles of the CFR govern respective regulated…

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…

For many professionals, writing skills are learned while they are on the job. In many cases, they would go by a preferred style or other documents or style guides that help to put a certain style in place. Editing, however, is rarely taught. Worse, the perception most people have of editing is that it is revising or rewriting a work. But the truth is different. Editing gives shape to a document. It helps to perfect and sculpt it. The big question most editors face…

Financial institutions have long been the most important source of payments for their customers. Of late, though, with an increase in competition and the advent of new non-bank entries into the marketplace, financial institutions have come under a lot more strain than they used to be.

Financial institutions need to reinvent themselves in a number of ways. They need to adapt novel strategies to…

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…

The importance of conducting a risk analysis updating it can be gauged from the fact that failure to conduct a written risk analysis qualifies as “willful neglect”, which carries the highest Civil Money Penalty (“CMP”). This cannot be waived by the DHHS unlike violations that happen due to a reasonable cause.

Since risk analysis is a required implementation specification under the Security Rule, failure to do one amounts to willful neglect. If the civil…

A common qualifying measure of physician ability is the medical specialty board certification. Because the requirements of the board are increasing; the laws that restrict such use are on the rise.

A webinar from MentorHealth, a leading provider of professional trainings for the healthcare industry, will offer learning on the new laws and qualifications of…

What can be and cannot be done with the use of personal devices under HIPAA is something practices and businesses that need to be compliant with the provisions of HIPAA need to be thoroughly aware of.

With changes expected in 2016 relating to personal devices as well as emailing and texting; staying compliant is extremely important to protect one’s practice or…