MedTech I.Q.

The Cutting Edge of Medical Technology Content, Community & Collaboration

Bari Shein
  • Female
  • Princeton, NJ
  • United States
Share on Facebook Share on Facebook Share

Bari Shein's Contacts

  • Jessica Hanson
  • frankille
  • Christine Stineman
  • Jim - medXcentral
  • Dr. Zakiuddin Ahmed
  • Trinity Cook
  • Charles Mandell MD,MBA
  • John A. Liebert, MD
  • Vincent Wright
  • Robert (Bob) E. Griffin
  • Michael Perry
  • Michael Blackstone M.D.
  • Cheryl merritt
  • mark sendo
  • Karen Detweiler

RSS

Compliance4all posted a blog post

Compliance4all posted a blog post

Establishing Latest Quality Systems in medical device and pharmaceutical industries

Establishing Quality Systems is one of the central aspects of a medical device and/or pharmaceutical organization. Establishment of Quality Systems is also a regulatory requirement, as set out by the FDA and the ISO.The process of establishment of Quality Systems for FDA-regulated medical devices industries is set out in 21 CFR Part 820. Further, the ISO has its standard for how to establish Quality Systems in medical devices industries –the ISO 13485 standard –which has to be implemented as part of a manufacturer’s Quality Management System.ISO 13485 primarily identifies and traces cleanliness in the area of work environment and helps to manage risks. Although it does not require alignment with 21 CFR Part 820 and other FDA QSR regulations; the two complement each other.Flexibility individualizes Quality SystemsDespite the assignment of specific tasks from each of these standards for establishing Quality Systems; there is an element of flexibility, because what precisely determines a Quality System varies from one firm to another, based on its values, mission and culture. In these cases, what medical device and pharmaceutical companies are required to do is to define and frame their own Quality Systems and then link them back to appropriate FDA definitions.This is of critical importance, because when an individual Quality System is framed uniquely for an organization and is not aligned to the respective FDA definition; it makes the company’s regulatory inspections preparedness difficult and laden with impediments. This is one of the fundamental aspects of compliance with FDA regulations.Professional learning on implementing the right Quality SystemsHow do medical devices or pharmaceutical companies build Quality Systems that are effective and are traceable to relevant FDA regulations? The ways of doing this will be the core of a webinar that is being organized by Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance.Louis Angelucci, who is a pharmaceutical professional and Certified Quality Engineer with over 20 years of experience in Quality Assurance, Quality Control, Validation, consent decree remediation, will be the speaker at this webinar.Want to gain complete knowledge of how to build Quality Systems that tie with relevant FDA definitions? Want to make sure that your Quality Systems pass FDA regulatory compliance requirements and do not invite penal actions from the regulatory body? Then, register for this learning session by visiting http://www.compliance4all.com/control/w_product/~product_id=501189?Wordpress-SEOAn explanation of regulatory requirementsDuring the course of this webinar, Louis will offer participants a perspective of the expectations of a Quality System as they apply to validation. He will also explain the requirements of regulations for the pharmaceutical and medical device industries.At this webinar on Quality Systems, which will hugely benefit professionals such as QA specialists, Quality Systems Specialist, Managers and Operators, Louis will cover the following areas:o  Regulatory expectation regarding Quality Systemso  How to establish Quality Systemso  Quality systems fundamentalo  FDA definitionso  Fitting within the FDA puzzleo  How to maintain and operate within a quality environment.https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/PostmarketRequirements/QualitySystemsRegulations/http://qualitymanagementsystem.com/iso-13485-saving-lives-through-quality-management/See More

Compliance4all posted a blog post

Compliance4all posted a blog post

Right now Medical device hazard analysis, the core of medical devices

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.So, what is medical device hazard analysis? Medical device hazard analysis may be defined as a structured method of analyzing the inherent and potential problems that a medical device could have at any stage of its production or after it is released into the market.The need for medical device hazard analysisMedical device hazard analysis has to be done for a number of reasons. It is required by the FDA as part of a product development Design Control Program. The FDA recommends ISO 14971 as the standard for medical device hazard analysis. This is because the ISO 14971 hazard analysis standard is considered the most comprehensive of all medical device hazard analysis tools.What makes this so is that the ISO 14971 takes risk into consideration in normal state, as opposed to other tools such as Fault Tree Analysis (FTA) and Failure Modes and Effects Analysis (FMEA), which only consider fault conditions. The latter two, in relation to the ISO 14971 standard, are more suitable for as tools for reliability rather than as those for product safety.However, despite the uses it has; medical device hazard analysis in relation to ISO 14971 is considered quite complex because of the free and broad implication of a few important terms, even if they are pretty straightforward in terms of their definitions. Some of the words that cause confusion over their interpretation when they are being put to practical use include:Hazard: Generally described as the potential site or basis of harmHazardous situation: A circumstance or situation which exposes people to a hazardous event or environmentHarm: Any degree of physical damage or injury from the medical device to the people working with it, or to the property or to the environmentCausative event: An event that may be said to be the source or cause of an adverse event in a medical deviceALARP: As Low as Reasonably Practicable, or judging how to weigh a risk against its benefits. This involves having to take a tricky decision in many situationsRisk index: A risk index is about assigning a score that will help determine the course of action when the risk index falls within categoriesResidual risk: The level or extent of risk that remains after all the measures for risk control have been implemented.There is more to medical device hazard analysis than theseThe fact of having to take all these plus other factors into consideration for medical device hazard analysis makes it a challenging matter, because medical device hazard analysis should be done in such a manner that nothing is left to chance.Want to understand the intricacies of medical device hazard analysis? Then, enroll for a highly relevant and absorbing session on medical device hazard analysis. This webinar is being organized by Compliance4All, a highly recognized provider of professional trainings for all the areas of regulatory compliance. Just log on to http://www.compliance4all.com/control/w_product/~product_id=501207?Wordpress-SEO to register.Clearing the confusion about terms in medical device hazard analysisAt this session, Edwin Waldbusser, who has been consulting in the US and internationally in the areas of design control, risk analysis and software validation, will be the speaker. He will throw light on all the confusing terms listed above. He will offer clarity on how to prepare a thorough medical device hazard analysis that will help those participating into this learning session.Edwin will go step by step through a template for hazard analysis to help clear the confusion about the meaning of these terms and make the process clear. He will discuss examples of hazards and hazardous situations and explain how to deal with residual risk. He will walk participants step by step through a typical medical device hazard analysis.Also explained in this session on medical device hazard analysis is the way of integrating Human Factors studies into the Hazard Analysis and how to integrate Hazard Analysis into the design program.In the course of this lively discussion on medical device hazard analysis, Edwin will cover the following areas:o  Explanation of Hazard Analysis termso  Hazard analysis process explanation using a templateo  Examples of terms will be giveno  Hazard analysis examples will be covered step by step.http://blog.greenlight.guru/iso-14971-medical-device-risk-managementhttp://www.fda-consultant.com/risk1.pdfhttp://nuhrise.org/wp-content/uploads/SOP-52-Adverse-event-reporting-for-medical-device-trials-SOP-NUH-sponsor-version-1.pdfhttp://www.hse.gov.uk/risk/theory/alarpglance.htmSee More

Compliance4all posted a blog post

Compliance4all posted a blog post

Works Quickly Meeting the FDA’s Quality and compliance requirements

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?This is simply not the case. Quality and compliance are built into a medical device product. It is only that companies need to have the capabilities needed for meeting Quality and compliance requirements from a regulatory perspective. If medical device companies have to be successful in their endeavors in the future, they have to be adept at how to meet quality and compliance requirements set out by the FDA.Quality and compliance to meet regulatory requirementsWhy is this needed? Simple: If medical device companies do not meet regulatory requirements set out by the FDA; they are not likely to meet the quality requirements demanded of their products. As a result, apart from being unable to create products that appeal to customers, they could end up facing punitive actions from the FDA.As said, meeting Quality and regulatory compliance requirements is not something of a gamble. Quality and compliance, which are the key inputs for meeting customer demands, can be fulfilled by putting a thorough process in place. These are capabilities a medical device company needs to have if it has to meet quality and compliance requirements and succeed in the market.Learn the ways of meeting Quality and regulatory requirements from the expertThe method by which medical device companies can achieve regulatory compliance requirements and ward off punitive actions from the FDA will be taught at a very interesting and lively webinar from Compliance4All.The speaker of this webinar, Susanne Manz, an accomplished leader in the medical device industry, who emphasizes Quality, compliance, and Six Sigma and brings extensive background in quality and compliance for medical devices from new product development, to operations, to post-market activities, will demonstrate just what medical device companies need to do in order to meet Quality and regulatory compliance.To gain complete insights into how medical device companies can take the requisite steps needed for meeting quality and compliance requirements, please enroll for this webinar by logging on to http://www.compliance4all.com/control/w_product/~product_id=501160?Wordpress-SEOAn explanation of the seven capabilities needed for meeting quality and compliance requirementsAt this session, Susanne Manz will explain that there are seven capabilities that are needed for medical device companies to accomplish their aim of meeting Quality and regulatory compliance requirements. She will explain these and offer complete understanding of how the changing regulatory climate needs to be comprehended. She will show how to evaluate one’s capabilities to develop a regulatory strategy that will help companies meet their requirements, so that they become successful in the pursuit of their objectives.Susanne will show how to develop strategy from one’s self-awareness of the Quality and regulatory requirements. At this webinar, she will cover the following areas:o  Evolving Regulatory Climateo  Seven Key Capabilities for Successo  How to evaluate and map your capabilitieso  Quality Planning and Improvemento  Maturity Modelingo  Developing Your Quality and Compliance Strategy.See More

Compliance4all posted a blog post

Compliance4all posted a blog post

Taxable and nontaxable fringe benefits

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.The IRS taxes certain kinds of fringe benefits that come under designated categories, while some other kinds of fringe benefits are not taxed. Taxable and nontaxable fringe benefits are a major aspect of taxation laws in the US and have to be implemented in strict accordance with what is set out in the law. There is a long list of taxable and nontaxable fringe benefits.A few examples of nontaxable fringe benefitsStock options, employee discounts, savings that are made for retirement planning and other related benefits are part of nontaxable fringe benefits. Also, certain types of De Minimis benefits, depending on their value, need not be accounted for and filed under W-2.A few examples of taxable fringe benefitsOther fringe benefits like accident benefit, vehicle that is provided from an employer and is for personal use, expenses incurred on vacation, and many other types of benefits are taxable and have to be accounted for and filed.When declaring and filing these, the right method has to be followed. Filing for the said taxable and nontaxable fringe benefits has to be done under the appropriate head, following the right procedures. The right knowledge has to go into understanding what to consider as taxable fringe benefits and what to classify as nontaxable fringe benefits. Claiming the fair market value of taxable fringe benefits is of the essence in making the declaration of taxable and nontaxable fringe benefits.Get to understand how to follow the right procedures for taxable and nontaxable fringe benefitsTo gain a complete understanding of these aspects of the IRS, please enroll for a valuable webinar from Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance. This session will give a complete understanding of how to classify taxable and nontaxable fringe benefits.At this important webinar, Greta Hicks, who is a former IRS Revenue Agent and Regional Training Coordinator, will be the speaker. She will take participants through all the important aspects of taxable and nontaxable fringe benefits that will help them understand how to get this right. To gain insights into how to get taxable and nontaxable fringe benefits right, please register for this webinar by logging on to http://www.compliance4all.com/control/w_product/~product_id=501196LIVE?Linkedin-SEOLearn about the taxable and nontaxable fringe benefits to avoid penaltiesThis webinar is highly useful for those who have some confusion about taxable and nontaxable fringe benefits. Since there are many items that are classified under both taxable and nontaxable fringe benefits; clarity on each of these will go a long way in helping to understand the correct method of filing.The learning from this webinar is important also because not only are the wrong expenses may disallowed by the IRS; filing under the wrong classification could result in penalties, too. Greta will offer complete clarity on benefits that can be hid in Sections 274, 162, 119, 132, 127, and 82. She will also give an understanding of numerous Announcements, Notices and Regulations, all of which have to be assiduously adhered to.In addition, she discuss a few areas of taxable and nontaxable fringe benefits that offer scope for ambiguity, such as:o  What are taxable and non-taxable as wages?o  Are meal allowances nontaxable?o  Are travel allowances nontaxable?o  What other benefits are nontaxable wages?o  What meals are 100% deductible and nontaxable to employees?o  What meals are 80% deductible and nontaxable to employees?o  What meals and entertainment are 50% deductible and nontaxable to employees?At this session, Greta will cover the following areas:o      Which benefits go on the w-2?o      Do any benefits go on a 1099?o      Fringe benefits you might be missingo      Accountable employee reimbursement plano      What employee benefits are non-taxable to employees?o      What/when expenditures are wages to employees?Fringe Benefit Examples and How They Relate to W2 and 1099 preparation:o      Accountable vs non-Accountable Expense Reimbursement Planso      Record keeping requirements of Sec. 274 & Accountable Planso      50%, 80%, and 100% Deductible Mealso      De Minimis fringe benefitso      No added cost benefitso      Cash paymentso      Auto allowanceso      Company vehicleso      Prizes, awards, giftshttps://www.hr360.com/Employee-Benefits/Fringe-Benefits/Introduction-to-Fringe-Benefits.aspxhttps://www.paychex.com/articles/finance/taxable-vs-nontaxable-fringe-benefitshttp://smallbusiness.chron.com/list-nontaxable-fringe-benefits-21172.htmlhttp://www.moneycrashers.com/taxable-fringe-benefits-income/https://justworks.com/blog/ins-outs-fringe-benefits-non-taxableSee More

Gifts Received

Gift

Bari Shein has not received any gifts yet

Give a Gift

 

Bari Shein's Page

Latest Activity

Vincent Wright liked Bari Shein's discussion The EHR 'killer app'
Jul 13, 2015
Bari Shein was featured
Jun 7, 2010
Trinity Cook and Bari Shein are now friends
Mar 12, 2010
Bari Shein was featured
Jan 26, 2010
Bari Shein was featured
Dec 14, 2009
Bari Shein was featured
Nov 24, 2009
Bari Shein's blog post was featured

7 YouTube Healthcare Videos Worth Watching - "Laughter is the Best Medicine"!

If you still think YouTube is just for those durned kids, you're really missing out. We at FierceHealthcare have decided to present seven of our favorite healthcare videos, with topics ranging from the serious (a critique of U.S. public health efforts in controlling H1N1) to the purely silly (an anesthesiologist singing about his duty to "sit and listen to the beep.")For their creativity, educational value and pure passion, we hereby deem these videos Fierce! Have fun checking them out; we…See More
Nov 18, 2009
Bari Shein and Jessica Hanson are now friends
Nov 3, 2009
Bari Shein posted a blog post

7 YouTube Healthcare Videos Worth Watching - "Laughter is the Best Medicine"!

If you still think YouTube is just for those durned kids, you're really missing out. We at FierceHealthcare have decided to present seven of our favorite healthcare videos, with topics ranging from the serious (a critique of U.S. public health efforts in controlling H1N1) to the purely silly (an anesthesiologist singing about his duty to "sit and listen to the beep.")For their creativity, educational value and pure passion, we hereby deem these videos Fierce! Have fun checking them out; we…See More
Nov 2, 2009
Bari Shein's blog post was featured

Obama Lashes Back at Insurance Industry Over Opposition to Health Plan

Article Tools Sponsored ByBy PETER BAKERPublished: October 17, 2009WASHINGTON — President Obama mounted a frontal assault on the insurance industry on Saturday, accusing it of using “deceptive and dishonest ads” to derail his health care legislation and threatening to strip the industry of its longstanding exemption from federalantitrust laws.Skip to next paragraphRelatedPresident Obama’s Weekly Address (whitehouse.gov)BlogThe CaucusThe CaucusThe latest on President Obama, the new…See More
Oct 18, 2009
Bari Shein updated their profile
Oct 18, 2009
Bari Shein's blog post was featured

Some Tandberg Holders Reject Cisco Offer - WSJ.com

Source: online.wsj.comShareholders representing 24% of the shares in Tandberg rejected Cisco's recent $3 billion offer for the video-conferencing equipment maker, fuelling hopes that the U.S.-based company might raise its bid.See More
Oct 15, 2009
Bari Shein and Christine Stineman are now friends
Oct 14, 2009
Bari Shein's blog post was featured

Senate panel backs healthcare reform

By John Whitesides and Donna Smith John Whitesides And Donna Smith – 34 mins agoWASHINGTON (Reuters) – A key U.S. Senate committee endorsed a sweeping healthcare overhaul on Tuesday, gaining the support of an influential Republican and delivering President Barack Obama a victory on his top domestic priority.The Democratic-controlled Senate Finance Committee approved the measure on a 14-9 vote, with Senator Olympia Snowe becoming the first Republican in Congress to back a healthcare reform…See More
Oct 14, 2009
Bari Shein was featured
Oct 13, 2009
Bari Shein joined Thomas GIannulli MD, MS's group
Thumbnail

mHealth

Mobile Healthcare Information Technology
Oct 6, 2009

Profile Information

Area of Expertise or Interest?
SEEKING OPPORTUNITIES IN eHEALTH.

Multi-talented professional skilled at developing new business, project management, marketing services, consultative selling and operations. Business liaison using technology to connect organizations/people.


Business development experience includes, but is not limited to, client-facing and sales support functions, aimed at gaining customers and penetrating new markets.

Marketing expertise includes account management, public relations, project management, market research, promotions, and Internet marketing.

Sales skills include establishing trust by building relationships to meet customer needs and provide cost effective solutions and performing post sale account management.

Operations management background includes project management, mapping and improving work processes, labor relations, and continuous improvement.
Specialties:

eHealth, project management, business development, consultative sales, business analysis, influencing skills, marketing, public relations, operations, communications, telecommunications, internet, cable TV, using technology to solve business problems, telemedicine, telehealth, EHR, HIE, vendor management, process improvement, change management, connected health, social networking, customer relationship management, health and wellness and distance learning
Type of Affiliation?
Industry

Bari Shein's Photos

Loading…
  • Add Photos
  • View All

Bari Shein's Blog

7 YouTube Healthcare Videos Worth Watching - "Laughter is the Best Medicine"!

Posted on November 2, 2009 at 5:17pm 0 Comments

If you still think YouTube is just for those durned kids, you're really missing out. We at FierceHealthcare have decided to present seven of our favorite healthcare videos, with topics ranging from the serious (a critique of U.S. public health efforts in controlling H1N1) to the purely silly (an anesthesiologist singing about his duty to "sit and listen to the beep.")



For their creativity, educational value and pure passion, we hereby deem these videos Fierce! Have fun checking them… Continue

Obama Lashes Back at Insurance Industry Over Opposition to Health Plan

Posted on October 18, 2009 at 6:41pm 0 Comments

Article Tools Sponsored By

By PETER BAKER

Published: October 17, 2009



WASHINGTON — President Obama mounted a frontal assault on the insurance industry on Saturday, accusing it of using “deceptive and dishonest ads” to derail his health care legislation and threatening to strip the industry of its longstanding exemption from federalantitrust laws.

Skip to next paragraph

Related

President Obama’s Weekly Address (whitehouse.gov)

Blog

The… Continue

Some Tandberg Holders Reject Cisco Offer - WSJ.com

Posted on October 15, 2009 at 2:05pm 0 Comments

Source: online.wsj.com
Shareholders representing 24% of the shares in Tandberg rejected Cisco's recent $3 billion offer for the video-conferencing equipment maker, fuelling hopes that the U.S.-based company might raise its bid.

Senate panel backs healthcare reform

Posted on October 13, 2009 at 8:44pm 0 Comments

By John Whitesides and Donna Smith John Whitesides And Donna Smith – 34 mins ago



WASHINGTON (Reuters) – A key U.S. Senate committee endorsed a sweeping healthcare overhaul on Tuesday, gaining the support of an influential Republican and delivering President Barack Obama a victory on his top domestic priority.



The Democratic-controlled Senate Finance Committee approved the measure on a 14-9 vote, with Senator Olympia Snowe becoming the first Republican in Congress to back a… Continue

"Meaningful" Progress Toward Electronic Health Information Exchange

Posted on October 2, 2009 at 12:22pm 0 Comments

A Message from Dr. David Blumenthal, National Coordinator for Health Information Technology



I recently reported on our announcement of State Health Information Technology Grants and grants to establish Health Information Technology Regional Extension Centers, as authorized under the Health Information Technology for Economic and Clinical Health (HITECH) Act provisions of the American Recovery and Reinvestment Act of 2009 (the Recovery Act).



Today I want to discuss the… Continue

Comment Wall (2 comments)

You need to be a member of MedTech I.Q. to add comments!

Join MedTech I.Q.

At 2:46pm on September 10, 2009, Dr. Zakiuddin Ahmed said…
Peace to you and yours

Thanks for accepting my invite & collaborating
Kindly let me know what is your specialty and interest areas so that we could explore some synergy

Take care

Zaki
zakiuddinahmed@gmail.com
At 6:55pm on July 23, 2009, CC-Conrad Clyburn-MedForeSight said…
Bari,

Ref: updates photo. I have just updated mine. This is how it works. Go to settings on the "Your Page" tab at top. Click browse under "Photos". Navigate to the new photo you want on your hardrive. Click open. It will uploafd your new photo when you click save on the "My Settings" page. Let me know if this works.

CC
 
 
 

© 2017   Created by CC-Conrad Clyburn-MedForeSight.   Powered by

Badges  |  Report an Issue  |  Terms of Service