All Blog Posts (1,642)

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 recertification upon full completion.

Overview:

A management system, by definition, is a process by which a function or…

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…

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…

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…

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…

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 FDA regulatory 510(k) clearance.

What makes preparing premarket…

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…

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…

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…

Cloud has given us the freedom and flexibility to work the way we want. For IT and network administrators the management of cloud environments to deliver a safe and great user experience is vital. We know terms shadow IT, zero day attack, Ddos attack, malware etc, some of us may even have felt the effects. The rise of cloud computing and big data is blurring virtual boundaries catalyst effect played by increasing mobile enterprises,among others.

The cloud security space itself is…

Today how we consume TV and Radio content is evolving at a rapid pace. From multiple screens to delivery mechanism like over IP etc, the industry is in constant transition. Broadcasting has gone from to few to many and so as how content is distributed and monitored today.

Broadcast monitoring software & solutions helps deliver easier, more comprehensive enterprise-wide system monitoring. With faster access to individual device data saves time during troubleshooting it contributes…

With the number of apps we use daily increasing we are more and more getting app savvy everyday. We use all kinds of apps entertainment, productivity, utility and more. On the other hand when it comes to an App developer or App marketer the task of getting noticed among millions of apps is quiet a challenge.

App promo or App promotional videos are used by many companies to connect with the user and pitch the benefits all in 30-60 seconds. Promo videos of apps significantly increase…

For marketers social media conversations and making meaning out of it is of immense priority. Whether you are looking to understand and measure Brand awareness, perception, sentiment, engagement or more Social Monitoring Tools are making this possible today.

When a company invests in social media analytics they make sense of their investments and efforts. These solutions can help collect data, take decisions, keep cost under control and more. Marketers use all sort of social…

Overview:

Supplier selection and management is one of the critical issues for medical device manufacturers. Suppliers provide materials and services to the device manufacturer, which means that they can be critical to performance and delivery of your device. Neither the FDA nor your notified body regulates your suppliers (with…