MedTech I.Q.

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All Blog Posts (1,642)

Why is credit card surcharge an issue for businesses?

The credit card surcharge issue has always been a tricky one in the US. Back in 2005, this issue was the subject of an antitrust lawsuit, and the resultant judgment, which came in mid-2012 prohibited credit card surcharge in ten States. Another 12 States are in the process of implementing their laws.

Although credit card regulations have traditionally opposed surcharging; companies have been circumventing merchant rules to ensure that credit card surcharge continues to be made. Even…

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Added by Adam Fleming on July 18, 2017 at 5:27am — No Comments

Understanding GLP's and their relationship with GMPs and SOP’s

Good Laboratory Practices (GLP’s) are a series of federal regulations passed in the US by the FDA under 21 CFR Part 58. In addition, Environmental Protection Agency (EPA) also has formed GLP’s both for Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) in 40 CFR Part 160 and for Toxic Substances Control Act (TSCA) in 40 CFR Part 792.

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GLP’s are Quality…

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Added by Adam Fleming on July 17, 2017 at 5:38am — No Comments

Entities should do everything it takes to avoid HIPAA fines and penalties

The fact of about 120 million individuals being affected by HIPAA breaches in 2015 highlights two important points:

  1. There is a mad demand for these records in the black market, which is why they are being targeted to this extent. Any wonder that PHI is in greater demand in the black market than even social security and credit…
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Added by Roger Steven on July 14, 2017 at 8:05am — No Comments

Steps to IEC 60601-1 approval

The 60601-1 is a standard that relates to the safety of medical electrical equipment. This harmonized standard is recognized by most countries around the world. Existing and new medical devices have to comply with the requirements set out in IEC 60601-1.

The IEC 60601-1 is going through its latest revision, its 3rd edition,…

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Added by Adam Fleming on July 14, 2017 at 6:27am — No Comments

The ways of applying ISO 14971, IEC 62304 and IEC62366-1 to medical device software

The ways of applying ISO 14971, IEC 62304 and IEC62366-1 to medical device software 3

Diligence, complete and proper examination and assessment of the gaps, and correction of the gaps right from the very start of product development are the core characteristics that need to go into implementing risk management of software used in medical devices.

These are the reasons for it:

  1. Lack of proper and complete implementation and gaps in them lead to major drawbacks such as production delays or…
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Added by John Robinson on July 13, 2017 at 6:47am — No Comments

How to control those risks and monitor the effectiveness of the controls put in place

Overview of this session Product Risk Management is a critical aspect of ensuring medical devices are safe and effective for intended uses. This course will help you understand the regulatory requirements, including ISO14971, and how to create processes and procedures to implement them.

You’ll learn techniques that can help you identify hazards and potential harms. You’ll learn how to mitigate risk and effectively monitor risk to ensure your customers receive safe and effective…

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Added by Adam Fleming on July 13, 2017 at 5:43am — No Comments

Understanding and responding to the special needs of college students who have autism

When people with autism spectrum disorder (ASD) –called just autism –enter college, they are up against challenges that are unique and peculiar to the group. They need to be understood for their special needs, because they enter college at a sensitive age. There is an onus on the part of the other people in the college, such as peer students and staff and those in…

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Added by Roger Steven on July 12, 2017 at 7:43am — No Comments

Do human factors matter in medical devices?

Do human factors matter in medical devices1

Is there a relationship between medical devices and human factors? This is a question that is seriously worth exploring. According to the ANSI/AAMI HE75:2009 document, human factors is an endeavor for optimizing the production of devices, systems, and many others concerned with them through the use of emotional, intellectual,…

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Added by John Robinson on July 12, 2017 at 6:21am — No Comments

Uniform Customs and Practice standard and can be negotiated by over 30,000 banks worldwide

Letters of Credit are the primary instruments for assuring payment of goods sold internationally. This web session is designed to provide attendees with an end-to-end understanding of the L/C (letter of credit) process. From the beginning of a contractual agreement, through the letter of credit application process and actual negotiation of the L/C, this information-rich webinar will provide techniques that are indispensable to both importers and exporters.…

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Added by Adam Fleming on July 12, 2017 at 5:23am — No Comments

How to deal with dynamic source data and the “refresh” concept

Microsoft Excel comes with a myriad of tools such as sorting, filtering, and subtotal to manage large lists of data. Yet, when it comes to analyzing all that data and doing it quickly, the MS Excel PivotTable is a very useful feature. It is particularly important and useful when the user is required to quickly create a compact summary report (based on lots of data) without needing to write complex formulas or rely on lengthy techniques.…

Excel

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Added by Adam Fleming on July 11, 2017 at 5:39am — No Comments

Preparing for HIPAA Enforcement

It goes without saying that preparing for HIPAA enforcement is of crucial importance to organizations. The reason: Last year saw a spike in the settlement payments ordered by HIPAA. There were as many as seven settlements of a value of over $1 million each. Of these seven, one was for $5.5 million, another was for $3.9 million, and yet another for $2.75 million. These constituted a part of a dozen or so overall resolutions settlements. These results point to the fact that HIPAA is continuing…

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Added by Roger Steven on July 10, 2017 at 8:34am — No Comments

Guarding against cyberattacks

Data breaches, malware and related frauds can cost an organization very dearly. The effects of cyber fraud are rather alarming:

It was estimated that cyberattacks amounted to a loss of at least a trillion dollars to the US economy in 2013, up by more than 25% over the previous year. The US continues to be the largest target and sufferer of cyberattacks. It accounts for more than a third of all cyberattacks that happen all around the world, followed by India, which is a distant second,…

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Added by Adam Fleming on July 10, 2017 at 5:19am — No Comments

Knowing what to expect in a HIPAA audit is the key to passing it

Knowing what to expect in a HIPAA audit is the key to passing it Healthcare professionals have to mandatorily carry out HIPAA audits in a way that satisfies the regulatory authorities. This needs a thorough understanding of the exact meaning and import of words contained in HIPAA. They also need to get a grasp of the purpose and intent conveyed in HIPAA’s language. This is absolutely essential for both the…

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Added by John Robinson on July 7, 2017 at 6:09am — No Comments

Understanding and dealing with Automated Clearinghouses (ACH) frauds

Automated Clearinghouses (ACH) are a popular means of financial transactions, as they substitute actual physical paper documents such as cards and checks. ACH’s are an electronic network that facilitate and carry out a huge number of transactions online. In being online and quick; they have grown as a byproduct of the IT revolution and have gained popularity around the world for the ease of payments they…

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Added by Adam Fleming on July 7, 2017 at 5:34am — No Comments

Mastering budget spreadsheets in MS Excel

Cash flow budgets, preserving key formulae and streamlining formula writing are just some of the varied functions of MS Excel. This wonder program helps the user to carry out a number of functions, all of which help in facilitating business decision-making. These apart; MS Excel offers users the opportunity to explore and carry out a vast range of activities, functions and calculations.

excel-ninja-course

An expert with a quarter of a century of working in the world of Microsoft…

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Added by Adam Fleming on July 3, 2017 at 5:20am — No Comments

Advantages and disadvantages of Electronic Health Records

Electronic Health Records (EHR) or electronic medical records (EMR), as they are called, are of enormous use in the fields of healthcare and medical sciences. They have a number of features that enable the patient; the medical professional and the healthcare provider have complete and unimaginably easy access to all important records that relate to the patient.

A direct result of the…

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Added by Roger Steven on June 29, 2017 at 7:52am — No Comments

Why does FDA think they can Regulate them, and why do others think they Cannot

This presentation will review the legal definition of medical device, and how it is applied by FDA to in vitro diagnostic tests. It will review the history of FDA interest in LDTs, and will describe the current situation with respect to Laboratory-developed tests. It will describe tests which have been cleared by FDA and those which have attempted clearance but not been cleared. It will discuss possible future actions by FDA and by the US laboratory community and assess their…

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Added by Adam Fleming on June 29, 2017 at 5:21am — No Comments

Safety Management and OSHA Compliance

Safety Management and OSHA Compliance 1

Why is Occupational Safety and Health Administration (OSHA) compliance necessary? For a simple reason: OSHA compliance is the surest legal way of ensuring safety at the workplace. Safety management and OSHA compliance go hand in hand and are deeply connected to and intertwined with each…

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Added by John Robinson on June 28, 2017 at 6:15am — No Comments

Documenting Software for FDA Submissions

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The Agile methodology is an important tool for software project management. It emerged out of the gradual efforts at arriving at a team based methodology of iterative software development. Its close association with software makes it as suitable to this field as Lean is to manufacturing.…

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Added by John Robinson on June 27, 2017 at 6:15am — No Comments

All about biosimilars –from development to registration

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Biosimilars can be described as near-copies of an original pharmaceutical product that another company may have manufactured. These products are versions of an original or innovative product, but are officially approved.

There is a misconception that they are similar to or are the same as generics, but this is not so in…

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Added by John Robinson on June 27, 2017 at 6:01am — No Comments

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