MedTech I.Q.

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November 2016 Blog Posts (25)

Editing skill for scientific writers

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…

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Added by Roger Steven on November 29, 2016 at 6:10am — No Comments

Making financial institution’s payment franchise stronger

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…

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Added by Compliance4all on November 25, 2016 at 5:03am — No Comments

Regulating Nanotechnology in food

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…

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Added by Roger Steven on November 25, 2016 at 4:50am — No Comments

The importance of “Management Responsibility” for medical device companies

Compared to bigger actions, Recalls, 483s, Warning Letters and consent decrees are only some of the milder parts of punishments that the FDA could impose on a medical device company that fails to meet regulatory requirements. The bigger actions can include seizure, injunction, and civil money penalties. The Park Doctrine allows executives to even be sentenced to prison.

In the…

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Added by Compliance4all on November 22, 2016 at 4:50am — No Comments

Controlling pests in food processing and foodservice

Food establishments continue to be a major source for pests due to the changes brought about in the means and ways by which food is produced and handled and in the ways of preparation techniques and eating habits. The pests in turn are sources for illness-causing microorganisms. The more knowledge about pest control at their disposal; the better it is for food processing and foodservice personnel, because this is essential for ensuring a safe food supply for consumers.…

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Added by Compliance4all on November 17, 2016 at 4:43am — No Comments

Lineament analysis as a modern tool to look for ore deposits

For those in the field of exploration, there is a need to zero in on an effective and affordable methodology that identifies prospective targets which are related to, or controlled by tectonic structures. This methodology should help explorers concentrate their exploration efforts over new areas keeping their budget in control, armed even with limited or nonexistent geological information.…

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Added by Compliance4all on November 16, 2016 at 4:47am — No Comments

Carrying out a HIPAA and HITECH risk analysis



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…

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Added by Roger Steven on November 15, 2016 at 5:23am — No Comments

Getting a grasp of the FDA’s New Enforcement of 21 CFR Part 11

That the FDA has become more rigorous in the enforcement of Part 11 through its new Part 11 and on-going data integrity inspection and enforcement program is evident in this: In just the last three years, it issued more than 30 Warning Letters with Part 11 and data integrity violations. The most common citations are related to not only inadequate integrity, security and availability of electronic records, but also to validation of software and computer systems.…

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Added by Compliance4all on November 15, 2016 at 4:44am — No Comments

Putting in place food processes that facilitate traceability and recall

The Food Safety Modernization Act (FSMA) has strengthened the FDA’s enforcement authority. The FDA now has the authority to not only mandate product recalls; the records and information they may request to see have increased as well. What has also gone up is the FDA’s documentation review authority.

Allergen mislabeling microbiological and foreign material contamination are the…

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Added by Compliance4all on November 14, 2016 at 4:38am — No Comments

Understanding the New Laws and Qualifications of the Specialty Board Certification

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…

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Added by Roger Steven on November 11, 2016 at 6:13am — No Comments

Managing a medical device recall efficiently and effectively

A medical device recall means the correction or removal of a device for human use where FDA finds that there is a reasonable probability that the device would cause serious, adverse health consequences or death. It is an action taken to address a problem with a medical device that violates FDA law. Recalls are made when a) a medical device is defective; b) when it could be a risk to health, or c) when it is both defective and a risk to health.…

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Added by Compliance4all on November 11, 2016 at 4:39am — No Comments

Understanding the myths and realities of HIPAA and BYOD

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…

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Added by Roger Steven on November 10, 2016 at 5:05am — No Comments

Making Big Data big in terms of effectiveness

Our world today is unthinkable without data. We seem to be flooded by it. Day in and day out, the world processes trillions of bytes. Big Data seems to be everywhere and has compounded our already heavy reliance on data.

But has this proliferation of data made any significant difference to our lives? Has it made our business decision-making any more effective or insightful?…

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Added by Compliance4all on November 10, 2016 at 4:23am — No Comments

Key Legal Considerations when Structuring Physician Employment Agreements



Compliance with the Stark Law has become more than just a compliance issue. It is an Enterprise Risk Management issue, as the substantial awards and settlements in recent enforcement actions indicate. Managing their compliance and…

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Added by Roger Steven on November 9, 2016 at 7:27am — No Comments

The criticality of determining the right sample size

Among the most important aspects that need to be taken into consideration in any application is the sample size. The sample size, when taken accurately, can be a very reliable guide to the whole. When the wrong sample size is taken for magnification, it could lead to wrong results, throwing the whole exercise into disarray. Determining the right sample size is thus of utmost importance to any application. There are scientific and verifiable means of doing this.…

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Added by Compliance4all on November 9, 2016 at 4:24am — No Comments

Ensuring sanitization of food products

Maintaining clean conditions in the entire food operation is essential for ensuring effective sanitation in the food industry. This can be brought about only when the residual microorganisms are destroyed after the production, storage and service areas of food establishments are cleaned thoroughly.

washing-tomato-2500 Ensuring a microorganism-free environment is a huge challenge for those in the food industry. This is because activities related to food, such as food production, handling,…

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Added by Compliance4all on November 8, 2016 at 5:01am — No Comments

An understanding of the EC 1223/2009

The European Co smetics Products Regulation (EC) 1223/2009 (CPR), which became fully operational from July 2013, is a game changer in many ways, as it is considered a most contemporary regulatory framework concerning state-of-the-art of cosmetic science and product technology.

It…

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Added by Roger Steven on November 8, 2016 at 4:57am — No Comments

Current trends in Maintaining an Effective CAPA Program and Using Risk Assessment Tools

A measure of the criticality of CAPA to medical device manufacture can be ascertained from the fact that the FDA considers the strength of a manufacturer’s CAPA program as the criterion for deciding how strong or weak he is. Given this fact, it pays to have a watertight CAPA system in place.

Risk-based CAPA is the latest stage in the evolution of the CAPA model. These days, the medical devices industry is using various risk-based approaches and tools to set-up,…

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Added by Compliance4all on November 7, 2016 at 4:52am — No Comments

Staying compliant with HIPAA’s fundraising requirements

Rules implementing The Health Insurance and Portability Act of 1996 (HIPAA) and Health Information Technology for Economic and Clinical Health Act of 2003 (HITECH) underwent changes as a result of amendments brought about by the US Department of Health and…

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Added by Roger Steven on November 7, 2016 at 4:33am — No Comments

Understanding the HIPAA’s requirements for safeguarding PHI

For an organization that needs to show HIPAA compliance; having the proper policies and procedures in place is as important as ensuring that it is providing the appropriate patient rights and controls on its uses and disclosures of Protected Health…

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Added by Roger Steven on November 4, 2016 at 6:28am — No Comments

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