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Medical device hazard analysis is of vital importance to a medical device. Medical device hazard analysis is at the heart of medical devices because if the device is not analyzed thoroughly for the hazard, or danger, that it poses, it is likely to cause problems of any kind to the user. Many a time, it becomes a matter of life and death. This is why medical device hazard analysis is of foremost importance.…
Added by Compliance4all on March 27, 2017 at 8:31am — No Comments
Quality and compliance are vital issues for any medical devices company. Despite the fact that the FDA’s regulatory compliance requirements are the same across the industry; many medical device companies are shocked when they receive a 483, or a Warning Letter, or even a consent decree. Is meeting the FDA’s regulatory requirements something of a chance, which some organizations get by fluke and others don’t?…
Added by Compliance4all on March 24, 2017 at 6:31am — No Comments
The Internal Revenue Service (IRS) has guidelines and laws for the way fringe benefits have to be taxed. First, an introduction to fringe benefits: Anything that is in addition to a person’s regular salary may be termed a fringe benefit. It is usually linked to an employee’s performance. Some of the common types of fringe benefits include children’s education, vehicle for commuting to the workplace and back, health insurance, retirement benefits and many others.…
Added by Compliance4all on March 20, 2017 at 6:23am — No Comments
Considered one of the most significant changes to be introduced into the American healthcare sector since the passage of the Affordable Care Act; the 21st Century Cures Act was one of the last legislative acts of outgoing president Barack Obama. Signed into law in December 2016; the 21st Century Cures Act seeks to strengthen medical research, foster innovation and accelerate the development of innovative treatments for chronic ailments such as cancer.…
Added by Compliance4all on March 16, 2017 at 6:00am — No Comments
Lyophilization and its validation and regulatory approaches form an important aspect of parenteral drugs.
Lyophilization is a process in which a product is frozen and placed in a vacuum and water is removed from it. This removes the need for the liquid stage in the change of ice from solid to vapor. This process consists of three phases: primary, sublimation and desorption.
Lyophilization is considered complex
Parenteral products such…
Added by Compliance4all on March 15, 2017 at 6:17am — No Comments
A financial organization, or an organization involved in any business for that matter, faces the prospect of receiving duplicate, fraudulent or late payments. These are the typical payment issues an organization is likely to face at some point of time in its business.
Payment issues are something almost no organization is likely to be free from. Duplicate invoice payments, just one of the payment issues an organization is likely to face, account for losses of…
Added by Compliance4all on March 13, 2017 at 6:02am — No Comments
That the inputted data should be “normally distributed” is a requirement of the calculations used in many statistical tests and methods. Typically, the methods used for Student’s t-Tests, ANOVA tables, F-tests, Normal Tolerance limits, and Process Capability Indices include such calculations.
A core criterion for ensuring the correct results is the one that the raw data used in such calculations be “normally distributed”. It is in view of this fact that the…
Added by Compliance4all on March 10, 2017 at 5:38am — No Comments
Design of Experiments (DoE) is an important component in many industries. It is a series of tests or runs that is carried out repeatedly and consistently over a period of time, and its outputs or responses, observed. Design of Experiments is very important in industry to help arrive at an understanding of the predictability and reproducibility of an experiment.
Added by Compliance4all on March 8, 2017 at 5:12am — No Comments
The International Financial Reporting Standards (IFRS) standards are a set of standards pertaining to different industries and their activities and practices. IFRS 6 relates to guidance in the accounting practices of the extractive industries, such as oil, mining and gas. The IFRS 6 accounting standard states the requirements, as well as the disclosures that need to go into accounting practices for expenses that a company incurs during the course of exploring and…
Added by Compliance4all on March 6, 2017 at 5:38am — No Comments
Financial statements are the ultimate indicator of a company’s financial health. Number crunching is a very important exercise that all executives at all levels of an organization need to be familiar with. Yet, given the heavy jargon that goes into financial statements and the complexity most of them have; many managers feel put off and don’t generally like to pore over financial statements.
The company’s financial statement is intended to provide insights into the…
Added by Compliance4all on March 3, 2017 at 5:35am — No Comments
Course "How to build a complete Safety, Health & Environment Management System through Standards & Practices" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC…Continue
Added by John Robinson on February 15, 2017 at 6:24am — No Comments
Humans can be calibrated, although most people like to think otherwise. The commonly used standard, Attribute Agreement Analysis, or what is called AAA, is a handy tool in helping to do this. At its barest, Attribute Agreement Analysis is a method in which the level of agreement or conformance between the appraisal made by the appraiser(s) and the standard is assessed. Then, the elements used for the appraisal that have the highest levels of disagreement with the standard are…Continue
Added by Compliance4all on February 15, 2017 at 5:54am — No Comments
The Design History File (DHF), the Technical File (TF) and the Design Dossier (DD) are core regulatory documents for a medical device. This is how one can understand the central difference between them: the Design History File (along with Design Control), is the most important among the regulatory documents that the FDA requires for medical devices, while the Technical File and Design Dossier are documents that serve the same purpose, however, within the EU’s regulatory…Continue
Added by John Robinson on February 13, 2017 at 7:29am — No Comments
Product Reliability is among the most important attributes for a product, no matter what kind of product one is considering. Product Reliability can be defined as the likeliness or probability of the product performing its stated purpose, in the light of the conditions under which it is going to be put, for a defined period of time.
The parameters used for quantification of Product Reliability are:
o MTBF or Mean Time Between Failures for products that can be repaired and…Continue
Added by Compliance4all on February 13, 2017 at 5:40am — No Comments
After carrying out the initial preclinical studies, drug manufacturers need to implement cGMP quality systems and risk management approaches during commercial development and operations in order to be able to meet the requirements of the FDA’s current Good Manufacturing Practice (cGMP), which are contained in and are governed by regulations 21 CFR parts 210 and 211.
The FDA’s guidance on cGMP quality systems and risk management approaches is meant to help drug manufacturers implement…Continue
Added by Compliance4all on February 10, 2017 at 6:08am — No Comments
Preparing premarket submissions that win regulatory approval is a complex task, even for the most seasoned professional in the medical devices industry. This is because of the highly stringent nature of the regulatory approval pathways, namely the Premarket Approval (PMA) process and…Continue
Added by John Robinson on February 10, 2017 at 4:19am — No Comments
Any company or individual that is required to submit IRS Form 1099 can avail a facility the Internal Revenue Service (IRS) has: the Taxpayer Identification Number (TIN) matching. This matching or likeness is among an assortment of e-services that gives what are called “authorized payers” the opportunity to match and state their own 1099 payee information with the pertinent records from the IRS. The TIN matching is a pre-filing facility, since it is done before an entity files information…Continue
Added by Compliance4all on February 8, 2017 at 5:58am — No Comments
Added by John Robinson on February 7, 2017 at 6:23am — No Comments
The in-vitro diagnostics (IVD) market is a diverse and fast changing one. Of late, one of the significant changes that happened to it resulted from the passage of the Final Rule. As part of the Affordable Care Act (ACA) or Obamacare, the Centers for Medicare and Medicaid Services (CMS) introduced the Final Rule to the 2014 Protecting Access to Medicare Act (PAMA) in mid-2016, which is set to make a significant impact on the in-vitro diagnostics market by delaying implementation of…Continue
Added by Compliance4all on February 6, 2017 at 6:21am — No Comments
All marketers dream would be to crack the online ad display for a brand and product. So do you need to be genius or data scientist to do this. Not really. The Ad management platforms have changed how ads are served and seen online today.
With the ability to push ads, manage ad budgets, across multiple devices is available today through a single platform. Multiple Ad management platforms seemingly looks alike talks about the same stuff, but they are not…Continue
Added by Richard Walter on February 3, 2017 at 3:14am — No Comments