MedTech I.Q.

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July 2017 Blog Posts (30)

Effective legal writing skills are essential for FDA submissions

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A number of reasons make cultivation of the art of effective legal writing skills for FDA submissions important. Documents that are submitted to the FDA are…

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Added by John Robinson on July 31, 2017 at 6:28am — No Comments

Ways of getting the PREDICT, ACE and the HTS right to smoothen shipping

In September 2014, the FDA deployed a new risk-based screening tool for imports called the Predictive Risk-based Evaluation for Dynamic Import Compliance Targeting (PREDICT). The main aim of PREDICT was bringing about improvement in screening and targeting of adulterated or misbranded goods or those that flout any of the FDA’s rules. The FDA seeks to bring this about by doing away with its legacy electronic system, OASIS’ admissibility screening function.

PREDICT is an important tool…

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Added by Compliance4all on July 31, 2017 at 5:28am — No Comments

Vital Stark Law considerations for physician employment agreements

Since the Affordable Care Act (ACA) –popularly called Obamacare –came into existence, there has been an exponential increase in the number of physician practice acquisitions. Some of the reasons that can be ascribed for this phenomenon are these:

-        Physician practice…

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Added by Roger Steven on July 28, 2017 at 7:30am — No Comments

Quality Assurance Auditing for FDA-regulated industries

Quality Assurance Auditing for FDA-regulated industries5

An effective audit constitutes the heart of an effective Quality System. The FDA and other regulatory agencies have emphasized this principle time and again. The purpose of an audit program is to ensure proper and thorough compliance with the guidelines set out by the regulatory agencies. A…

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Added by John Robinson on July 26, 2017 at 5:52am — No Comments

The centrality of Risk Analysis to HIPAA

Carrying out audits is among the most important requirements for any organization that handles Protected Health Information (PHI). HIPAA hosting providers, who implement safeguards in the manner specified in the HIPAA Privacy Rule, must be…

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Added by Roger Steven on July 25, 2017 at 8:00am — No Comments

Which universities are pushing the boundaries in life sciences?

If you had to name the branch of university research that has the most tangible impact on mankind’s day-to-day activities, it is likely that the life sciences would be near the top of the list: not many days go by without the announcement of a new drug or gene discovery that has the potential to change lives or tackle disease.

Much of the best research in these fields takes place in the ultra-elite universities that excel in subjects across the…

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Added by John Robinson on July 25, 2017 at 6:14am — No Comments

Implementing ICH guidelines-compliant validation

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Professionals in the field of statistical analysis need to possess clarity on understanding and interpreting statistical concepts used to investigate quantitative ICH Guidelines, such as:

  • Analytical methods validation
  • Procedures and acceptance criteria in calibration limits…
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Added by John Robinson on July 24, 2017 at 6:07am — No Comments

Sources of contamination that exist in a clean room environment

Aseptic technique is one of the methods used in eliminating or at least minimizing contamination in pathogens. It is also used to make compounding sterile products. Sterilized equipment, sterile apparel, high degree of processing, and cleaning on a continuous basis make up the important procedures used in aseptic technique.

The main aim of aseptic technique in cleanrooms is to ensure that the sterile product is sterile, safe and effective. Ensuring this is all the more important for…

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Added by Compliance4all on July 21, 2017 at 6:08am — No Comments

An integrated approach is needed for Complaints Handling, Adverse Event Reporting, and Recalls

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The fact that medical device manufacturers work and operate in various regulatory systems whose requirements are different and not always consistent with each other is recognized and empathized by the…

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Added by John Robinson on July 21, 2017 at 5:56am — No Comments

Understanding opportunities in NAFTA

The North American Free Trade Agreement (NAFTA) came into being on the first day of 1994. While the US and Canada had been having free trade agreements that go back at least three decades culminating in the US-Canada Free Trade Agreement of January 1, 1989; NAFTA became a reality following Canada’s entry in 1991 into the bilateral talks between the US and Mexico, creating the trilateral FTA.

One of the primary objectives of the NAFTA was the elimination of a number of duties and…

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Added by Compliance4all on July 20, 2017 at 5:26am — No Comments

Training and Development is a highly developed and evolved, broad body of knowledge. Many employees place themselves at a disadvantage vis-à-vis their colleagues in the absence of the right professio…

Development of technical training in the life sciences3

Training and Development is a highly developed and evolved, broad body of knowledge. Many employees place themselves at a disadvantage vis-à-vis their colleagues in the absence of the right professional training and development. If employees have to consistently close gaps in their learning, they need to keep…

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Added by John Robinson on July 19, 2017 at 6:21am — No Comments

How to create processes and procedures to implement them?

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.

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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 products. A rigorous…

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Added by Compliance4all on July 19, 2017 at 5:47am — No Comments

Ensuring compensation-focused compliance with Stark Law considerations

Stark Law compliance is now more than just a compliance issue. It has grown to become an Enterprise Risk Management matter, if the substantial awards and settlements in recent enforcement actions are anything to go by. For healthcare organizations that develop and implement provider contracts;…

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Added by Roger Steven on July 18, 2017 at 7:50am — No Comments

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 Compliance4all 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.

Biotechnology concept

GLP’s are Quality…

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Added by Compliance4all 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…
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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 Compliance4all 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

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