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Kidney stones, also known as renal calculi, occur when the liquid stored in the kidneys becomes too concentrated. The stone, once lodged in the urinary tract, obstructs the urine flow from it and causes great pain in the abdomen. Other symptoms of a kidney stone include a burning sensation or an intense desire to urinate frequently. Also experiencing frequent urge to pass urine. Kidney stones can be treated effectively, due to presence of advanced methods and associated medical devices. Kidney stone management devices are widely used to retrieve kidney stones. Increasing prevalence of kidney stones and the increasing preference for minimally invasive surgeries worldwide is expected to propel the growth of the kidney stone management devices market. For instance, according to the United States National Kidney Foundation, every year, more than half a million people go to emergency rooms for kidney stone problems. It is estimated that one in ten people will have a kidney stone at some time in their lives. Moreover, increasing product launches, technological advancements, and increasing research and development activities for the prevention and treatment of kidney stones is expected to augment the growth of the kidney stone management devices market. For instance, in August 2020, Dornier MedTech (Dornier) announced the launch of UroX, a community that connects professionals from various disciplines to cultivate innovation and solve the most pressing challenges in urology. Read more @ https://coherentmarketinsights-blog.blogspot.com/2021/02/increasing-prevalence-of-kidney-stones.html

Course "Key Factors to Write an Effective Standard Operating Procedure (SOP) and Work Instructions (WIs)" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: Writing SOPs or procedural documents can be challenging at times. However, writing SOPs is overall a straightforward process. However, enforcing what you already created and implemented in the pipeline is another story. The term SOP is very obvious. We have seen "clearly written description of how specific tasks are to be done." Another satisfactory definition would be "detailed written instructions that achieve the uniformity of the performance of a specific function." Is the firm doing what the regulations specify? Is the firm doing what their procedures specify? If you are medical device or a pharmaceutical manufacturer, these definitions come as no surprise because when it comes to FDA regulations and guidance documents "establish" means to define, to document (in writing or electronically) and to implement. The goal and emphasis with FDA is simple. Proof of "Establish" is the foundation. Is the firm doing what the regulations specify? Is the firm doing what their procedures specify? Are the procedures being followed and enforced by company personnel? SOPs are needed in regulated industries to give step-by-step instructions for performing a particular job or task. This session will provide a step-by-step overview and a snapshot of the procedure description, the process and format. The subject matter of a SOP may range from how to operate a piece of machinery to how to log into a particular software program. SOPs ensure consistency and reliability because they require training of all affected parties. This session will address recent enforcement actions for SOP related violations but no surprise. Most of our enforcement actions are documentation related, i.e., SOP or other procedural documents. We will review examples from

Course "Internal Auditing for the Medical Device Industry" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: This course provides an overview of internal auditing requirements and techniques for medical device companies as a method for risk management and quality improvement. The course will cover auditing requirements, audit planning, preparation, knowledge, auditor skills, interviews, documents and records review, objective evidence, audit report writing and corrective action. Why should you attend: Attendees should attend this seminar for risk management and improvement purposes to identify weaknesses, problems, compliance risks, and improvement opportunities. Who Will Benefit: * Quality Manager * Quality Associate * Quality Engineer * Quality Technician * Regulatory Associate Agenda: Day One Lecture 1: Overview of an auditing program, principles of quality management systems and how they related to auditing, benefits of auditing, and what is auditing. Lecture 2: Types of audits, auditor qualifications, ethics, responsibilities, audit phases, audit planning, and scheduling. Lecture 3: Conducting audits, interview techniques, objective evidence, data collection, tracing, use of checklists, and reviewing documents and records. Lecture 4: Conducting process audits, running closing meetings, audit report writing, corrective actions, and improvement Day Two Lecture 1: Overview to auditing to ISO 13485 and FDA QSR. Global differences which affect auditing approaches, auditing document control and record keeping, management responsibility, and resource management. Lecture 2: Auditing order handling, design control, purchasing, and supplier controls. Lecture 3: Auditing production, validation, and preservation. inspection and testing, control of test equipment, customer property, and sterilization Lecture 4: Auditing customer feedback, internal auditing programs, complaint

"Global Medical Devices Survey 2013-2014" is a new report by ICD Research that analyzes how medical devices industry companies' procurement expenditures, business strategies, and practices are set to change in 2013-2014.

Overview: This lesson will be going into great detail regarding you practice or business information technology and how it relates to the HIPAA Security Rule, in particular portable devices and personally owned devices. Areas covered will be texting, email, encryption, medical messaging, voice data and risk factors as they relate to IT. I will uncover myths versus reality as it relates to this very enigmatic law based on over 600 risk assessments performed as well as years of experience in dealing directly with the Office of Civil Rights HIPAA auditors. I will also speak to real life audits conducted by the Federal government (I've been on both sides of these audits) what your highest risks are for being fined (some of the risk factors may surprise you). In addition this course will cover the highest risk factors for being sued for wrongful disclosures of PHI and the manner in which patients are now using state laws to sue for wrongful disclosures.  Don't always believe what you read online about HIPAA, especially as it relates to encryption and IT, there are a lot of groups selling more than is necessarily required.  Why should you Attend: HIPAA NOW HAS TEETH! Be prepared for what's new in 2016! Protect your practice or business! What factors might spurn a HIPAA audit? …are you doing these things? Why are the Feds enforcing after all these years?  It is important to understand the new changes going on at Health and Human Services as it relates to enforcement of HIPAA for both covered entities and business associates as it relates to portable devices, texting, and emailing of PHI. You need to know how to avoid being low hanging in terms of audit risk as well as being sued by individuals who have had their PHI wrongfully discloses due to bad IT practices. I have also been expert witness on multiple court cases where a business or medical practice is being sued for not doing their due diligence to minimize risk.  Areas Covered in the Session: Update

The last 2 decades have witnessed an increased use of digital devices due to major advancements in information technology. These advancements have harmed adversely, the most important buddy in our body - The Eye. Devices like desktop and laptop computers, televisions, e-readers, smartphones, tablets, gaming gadgets have impacted our eyes massively which causes digital eye strain. This is a temporary discomfort to eyes that generally follow 2 or more hours of digital device use as people tend to switch between such devices repeatedly or use one for longer periods. Signs of Digital Eye Strain? 1.) Headaches 2.) Eye fatigue 3.) Irritated, dry, or red eyes 4.) Neck, shoulder, and back pain 5.) Blurred vision To know the prevention and treatment methods for Digital eye strain visit the blog

"World Medical Device Packaging". World medical device packaging product demand will increase 5.9 percent yearly to $25.7 billion in 2017.

Endoscopy Devices: Making Pathways in Diagnostics and Therapeutics.Several diseases that require the use of endoscopy devices for diagnostics, as well as therapeutics, have been on the rise across various countries. The clinically unmet demands of such diseases in developing nations have resulted in a flourishing growth for the global endoscopy devices market.

Apple has joined forces with Eli Lilly and Evidation Health on a new feasibility study to detect evidence of brain decline with data from personal digital devices. The research has revealed that these devices may help in the identification of mild cognitive impairment (MCI) and Alzheimer's disease dementia.

Increasing Focus on Aesthetic Appeal and Growing Geriatric Population to Augment Growth of Skin Rejuvenation Devices Market Skin rejuvenation is basically a cosmetic surgery, which aims to bring about a more youthful appearance of the face. Various facial rejuvenation techniques can be used to accomplish this goal. Such procedures can range in depth and Invasiveness of treatment. It is important for you to understand the kind of skin care treatment that would be best suited for your specific goals and preferences. Increasing focus on aesthetic appeal is expected to propel growth of the skin rejuvenation devices market. For instance, according to a 2018 survey by Global Data, around three quarters of South Korean men undertake a beauty or grooming treatment at least once a week. Moreover, increasing geriatric population is also expected to aid in growth of the market. For instance, according to the U.S. Census Bureau, the U.S. geriatric population is expected to reach 77 million by 2034. Increasing expenditure on personal care products is expected to offer lucrative growth opportunities for players in the skin rejuvenation devices market. For instance, according to the U.S. Bureau of Labor Statistics, average annual expenditure on personal care products in the U.S. increased from US$ 707 in 2016 to US$ 768 in 2018. Read more @ https://coherentmarketinsights-blog.blogspot.com/2020/12/increasing-focus-on-aesthetic-appeal.html

Overview: This lesson will be going into great detail regarding your practice or business information technology and how it relates to the HIPAA Security Rule, in particular portable devices. Areas covered will be texting, email, encryption, medical messaging, voice data and risk factors as they relate to IT. I will uncover myths versus reality as it relates to this very enigmatic law based on over 600 risk assessments performed as well as years of experience in dealing directly with the Office of Civil Rights HIPAA auditors. I will also speak to real life audits conducted by the Federal government (I've been on both sides of these audits) what your highest risks are for being fined (some of the risk factors may surprise you). In addition this course will cover the highest risk factors for being sued for wrongful disclosures of PHI and the manner in which patients are now using state laws to sue for wrongful disclosures. Don't always believe what you read online about HIPAA, especially as it relates to encryption and IT, there are a lot of groups selling more than is necessarily required. Why should you Attend: HIPAA NOW HAS TEETH! Be prepared for what's new in 2016! Protect your practice or business! What factors might spurn a HIPAA audit? …are you doing these things? Why are the Feds enforcing after all these years? It is important to understand the new changes going on at Health and Human Services as it relates to enforcement of HIPAA for both covered entities and business associates as it relates to portable devices, texting, and emailing of PHI. You need to know how to avoid being low hanging in terms of audit risk as well as being sued by individuals who have had their PHI wrongfully discloses due to bad IT practices. I have also been expert witness on multiple court cases where a business or medical practice is being sued for not doing their due diligence to minimize risk. Areas Covered in the Session: Updates for 2016 BYOD Portable devices B

Practical steps to compliance with HIPAA Computer Policy: That the HIPAA has a clear and stringent policy on computers is absolutely understandable, because computers constitute the very soul of HIPAA. Ensuring security of patient data is one of the core causes for which HIPAA was enacted; so, it is only natural that Computer Policy should be at the center of HIPAA compliance. A HIPAA Computer Policy rule came into effect in 2005. The nub of this enactment is to ensure that there are technical, physical and administrative security procedures that must be adhered with. These are meant for Covered Entities to ensure that the data they have of patients, namely electronic Protected Health Information (PHI) is safe and secure. Understand the reason for HIPAA Computer Policy Any implementation has to start with an understanding of the rationale for the action, right? The same goes for something as important and big as implementation of HIPAA compliance into systems. HIPAA Computer Policy is in place for a specific and critical reason ���protection of patient data, loss of which can lead to hefty penalties that can affect the business very adversely. So, installing the necessary protections is the first step to protecting vital data and with it, one's own business or practice, as well. Implement a sound access policy A strong access policy is at the heart of HIPAA Computer Policy. It is in the computer systems that all the data relating to the patient are stored. So, making sure who in the organization has access to these and how and when, is very important. Not only should access be restricted to only designated and permitted personnel in the organization; there should be a system by which tracking of access is easily determined. This is to find out who accessed which record, when, what action followed, what happened as a result of this access, and so on. Keep a record of all system components This is another step to ensuring compliance with HIPAA Computer Po

Course "Verification vs. Validation - Product Process Software and QMS" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: This course will review the company Master Validation Plan for major key inputs and CGMP deficiencies. It will address the FDA's newer and tougher regulatory stance. This course's aim is to prove "Product Risk Based V&V" by sufficient, targeted and documented risk-based V&V test case elements/scripts. It will teach participants to evaluate its elements against ISO 14971 and ICH Q9 for hazard analysis and product risk management. This course will evaluate different field-tested, U.S. FDA-reviewed V&V protocols; how to employ equipment/process Requirements Specs / DQs, IQs, OQs, and PQs, or their equivalents per ASTM E2500, all against a background of limited company resources. It will review a matrix that simplifies "as-product", in-product", process and equipment, et al, software VT&V, to assure key FDA requirements are not overlooked. While considering the QMS and 21 CFR Part 11; this course will make practical application of these same in two hands-on sessions. Why you should attend: This session helps participants: * Understand Verification and Validation, differences and how they work together; * Discuss recent regulatory expectations; * Know how to document a "risk-based" rationale, and use it in a resource-constrained environment; * Determine key "milestones" and "tasks" in a project; * Locate and document key subject "inputs"; * Compile "generic" Master and Individual Validation Plans; * Learn the key element of a Product V&V File/Protocol; * Understand how to develop Process and/or Production/Test Equipment V&V Files/Protocols; * Get a grasp of basic Test Case construction; * Understand sample sizes and their justification; * Learn the key elements of Software V&V expected by the FDA and how to document; * Deal with hardwa

Overview: This lesson will be going into great detail regarding your practice or business information technology and how it relates to the HIPAA Security Rule, in particular portable devices. Areas covered will be texting, email, encryption, medical messaging, voice data and risk factors as they relate to IT. I will uncover myths versus reality as it relates to this very enigmatic law based on over 600 risk assessments performed as well as years of experience in dealing directly with the Office of Civil Rights HIPAA auditors. I will also speak to real life audits conducted by the Federal government (I've been on both sides of these audits) what your highest risks are for being fined (some of the risk factors may surprise you). In addition this course will cover the highest risk factors for being sued for wrongful disclosures of PHI and the manner in which patients are now using state laws to sue for wrongful disclosures. Don't always believe what you read online about HIPAA, especially as it relates to encryption and IT, there are a lot of groups selling more than is necessarily required. Why should you Attend: HIPAA NOW HAS TEETH! Be prepared for what's new in 2016! Protect your practice or business! What factors might spurn a HIPAA audit? …are you doing these things? Why are the Feds enforcing after all these years? It is important to understand the new changes going on at Health and Human Services as it relates to enforcement of HIPAA for both covered entities and business associates as it relates to portable devices, texting, and emailing of PHI. You need to know how to avoid being low hanging in terms of audit risk as well as being sued by individuals who have had their PHI wrongfully discloses due to bad IT practices. I have also been expert witness on multiple court cases where a business or medical practice is being sued for not doing their due diligence to minimize risk. Areas Covered in the Session: Updates for 2016 BYOD Portable devices B

Overview: Essentially, covering in 90 minutes the basics of E everything that applies to your clinical work. We will give you the questions to ask your IT people, because you should not implicitly trust them, because the law will hold you accountable more than them. We will first cover the general principles of electronic compliances as laid forth in HIPAA. We will then discuss how this applies to your desktop/laptop/iPads and smart devices, other electronic equipment such as routers and modems. We also cover the use of email, secure mail and your EHR/EMR. We will discuss the pros and cons of using the cloud for your data storage and EHR/EMR, i.e. knowing what a HIPAA compliant data center looks like. Principles in the use of encryption and passwords and other security principles will also be covered. Why should you Attend: Unless you are 100% sure you've thought through every angle of your patient's electronic PHI and you sleep like a baby never concerned about this then you need to attend. If you have any questions about the details of what electronic compliance looks like and how it's applied in day-to-day clinical and business activities, interactions with vendors, EHR/EMR, your relationship with your ISP and IT providers, use of all electronic devices, then this workshop is for you. It also gives you principles to apply in new situations which are likely to arise frequently. If you wrote the book on this it would be out of date in 24 hours, so what's important is to learn how to think about these things and use your resources to stay ahead of the game. If you are confident you have the basics covered on every item listed below then this seminar is not for you. Areas Covered in the Session: HIPAA electronic compliance Secure use of EHR/EMR Email and secure mail use Encryption and password security principles Interfacing with the public Interfacing with vendors such as ISPs and other telecommunication companies Backups Cloud use How to know your data center

The Physician Payment Sunshine Act: The Physician Payment Sunshine Act, also called Physician Payments Act, is a piece of legislation passed by the American Congress in 2010. It came to be enacted along with the Affordable Care Act, or Obamacare. The purpose of this legislation is to ensure transparency in the financial relationships that exist between the pharmaceutical industry, teaching hospitals, and physicians. What the Sunshine Act requires is this: Manufacturers of drugs and medical devices, and organizations that purchase in groups (Group Purchasing Organizations or PGO's) have to report payments or their equivalent that they make to physicians and teaching hospitals. Items that are considered equivalent to money payments, transfers of which have to be reported are clearly mentioned. These include the following: Meals Honoraria or grants Gifts Entertainment Speaking fees Writing services, such as research papers or manuscripts Travel reimbursements Purchase of items such as teaching materials and journals, which are paid either directly to physicians or teaching hospitals, supplied either directly or through a third party Funding for research Another core reporting requirement: Another requirement of the Sunshine Act is that when manufacturers of drugs and medical devices and group purchasing organizations have physicians who have a stake in some or another form in their organizations; this has to be reported to the Centers for Medicare and Medicaid Services (CMS). These reporting requirements apply to all kinds of physicians, who are either specialists or are general practitioners. However, the following are excluded from reporting by the Sunshine Act: Nurses Support and office staff Residents Medical students Physicians assistance Advance practice nurses Physicians need not report: The Sunshine Act requires information about these payments and transfers to be made by the paying medical device and drug companies, and not by physicians.

Course "Fundamentals of Statistical Process Control: Implementation and Assurance of SPC" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: This 2-day seminar provides the information you need to use one of the most powerful tools in quality, statistical process control. It will help people in design, quality, and production understand the concepts and effectively implement them. The examples and issues in the seminar come primarily from the medical device industry, but the material is applicable to any production environment. Production process must be controlled to help ensure they are stable. While there are many control methods, the most powerful and often used is statistical process control, SPC. It uses data from the process itself to detect changes - changes that could result from an unstable process. SPC helps determine if a process continues to operate the way it was set up. If not, SPC produces a signal that calls attention to the problem. One very important application is process capability analysis. With a stable process, SPC data can help determine if the process is capable of meeting the product specifications. These are often expressed as process capability indices. Continuous improvement programs can use the information generated by SPC to monitor process variation and identify its causes. These methods can reduce cost, improve product, and enhance customer satisfaction. Why should you attend: Manufacturing companies, especially medical device manufacturers, must control process. Not only is this a regulatory requirement, but is a good business practice. Without a solid understanding of SPC, you put yourself and your company at a disadvantage. On a personal basis, the material in this seminar will help improve your skills; it aligns with the ASQ Body of Knowledge for the Certified Quality Engineer, Green Belt, and Black Belt. These are areas you should master

"Endoscopy Devices: Applications and Global Markets"This report provides a comprehensive analysis of the global market for endoscopy services and equipment.

Medical sensors are becoming an integral part of medical facilities throughout the world. They enable facilities to monitor all aspects of patient care, from room temperature to vital signs, from pulse rates to oxygen levels, and more. This is a new frontier in patient care that has the potential to dramatically save money and reduce staff fatigue. A medical sensor system can include a variety of different instruments in various formats, ranging from a simple temperature probe attached to a belt clip to highly sophisticated electronic devices capable of monitoring dozens of different parameters. The most common type of medical sensor is a small portable electronic device that is affixed to a person's skin or clothes. These are designed for use in a wide variety of patient care settings including hospitals, rehabilitation centers, and home health care agencies. They are often used by cardiologists and nurses to monitor heart rates and pulse rates as well as measurements of blood pressure and respiration. Increasing demand for medical sensors is expected to propel growth of the global medical sensors market. For instance, 2020, OSI Systems, Inc. announced that its Optoelectronics division received an order to provide optical sensors for use in medical devices from a leading healthcare original equipment manufacturer. Moreover, high prevalence of chronic diseases is also expected to aid in growth of the market. Read more @ https://sachinbhombe.blogspot.com/2021/03/increasing-demand-for-medical-sensors.html

Cardiac markers are special antibodies measured in the blood to measure heart function. They can also be used in the detection or early diagnosis of certain diseases. Although they're usually associated with myocardial infarction, they can also be indicative of many other conditions. For instance, hyperthyroidism and thyroid prophylaxis can result in an elevated elevation in plasma marker levels. As per the American Heart Association (AMA), in 2016, cardiovascular disease accounted for 17.6 million deaths across the globe. The ECG is one of the most useful cardiac marker testing device. It measures the cardiac output and provides detailed information about heart conditions. This test is used to diagnose heart diseases and the complications that can arise from the disease. ECG is one of the most widely used tests. ECG is conducted while the patient is lying down on the table. A technician places electrodes either in or on the skin surface. The test is normally performed for different purposes. Read more @ https://coherentmarketinsights-cmi.blogspot.com/2021/03/cardiac-marker-testing-devices-have.html