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Course "Supplier Management for Medical Device Manufacturers" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. 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 a few exceptions). They expect you to have an effective process to ensure your suppliers perform in the regulatory environment. How well do you understand the requirements for supplier management? Could you pass a regulatory audit or inspection without any issues? This course delivers the tools, templates, and methods to help participants implement an effective and efficient supplier management program. This two-day hands-on course provides a clear understanding of the underlying principles of supplier management. The course uses exercises to solidify understanding. In addition, the course uses FDA Warning Letters to illustrate the points and help you learn from others. As part of the practical implementation, the course includes receiving acceptance activities, outsourced processes, process validation at the suppliers' location, supplier auditing techniques, and supplier issues in management review. The course uses the Global Harmonization Task Force (GHTF) framework, but expands it to cover other issues and techniques important in effective implementation. Why should you attend: Since FDA regulations do not allow them to audit your suppliers unless they make finished medical devices, they require that you have sufficient control over them. But from time to time the FDA makes a reinterpretation of what this means. This happened within the last f 5 years, so if you supplier management program is older than that, you need to make major changes in you supp

A gynecological device is a medical device that is used to promote female health or to protect and preserve reproductive health for females. This is a very broad category and includes products such as watches, calculators, bandages, and hygienic towels. While many of these products have been clinically tested and found to be safe for female health, there are still a few devices in the market that pose threats to female reproductive health. Gynecological devices usually fall into three categories: medical devices, biological safety devices, and mechanical devices. Medical devices are those that prevent the risk of injury or trauma to a woman's reproductive organs from medical interventions. Biologic safety devices are those that protect a female's health by promoting female reproductive health. Finally, mechanical devices are those that help maintain a woman's reproductive health and allow her to achieve or reach their desired fertility or pregnancy. The use of any of these unsupervised or unsafe medical procedures poses a risk to a woman's reproductive health and should be avoided at all costs. The main factors driving the growth of the gynecological devices market are the rapid increase of gynecological diseases such as uterine fibroids, endometriosis, and vaginitis and the introduction of new innovative gynecological devices in the market. For instance, according to the U.S. National Center for Biotechnology Information, approximately 97 per 1000 women suffer from gynecological diseases in the U.S., among which approximately 53 per 1000 women suffer from menstrual disorders. Rising awareness about gynecological health and preventive check-up to avoid sexually transmitted diseases (STD) is expected to boost the market growth. Moreover soaring numbers of surgical procedures such as female sterilization, endoscopy, laparoscopy, and ablation are driving the demand for gynecological devices. However strict regulatory orders by governmental bodies across the globe rel

Patient warming devices come in many forms, each designed for a specific purpose. For example, some devices are made for offices that are out of the way or for doctor offices that are smaller in size. In addition, these applications are very easy to operate and can be used without requiring a great deal of training on the part of the patient or the medical professional using the device. However, there are certain devices that are extremely efficient and are recommended by both practitioners and medical associations across the country. An increasing number of surgical procedures is expected to drive the growth of the global patient warming devices market. According to the National Health Statistics Reports, in 2017, around 48.3 million surgical and nonsurgical procedures were performed in the U.S. with around 25.7 million ambulatory surgery procedures being performed in hospitals, while 22.5 million being performed in ambulatory surgery centers (ASCs). Patient warming devices are widely used in surgical procedures, which cover before and after surgery. As a result of this, the demand for patient warming devices has increased significantly. Hence, these factors are expected to drive growth of the global patient warming devices market. Read more @ https://coherentmarketinsights-blog.blogspot.com/2021/02/patient-warming-devices-market-is.html

Radiofrequency ablation is a relatively new method of reducing pain associated with back pain. In a recent review published by an organization that studies medical innovations, the Global Commission on Systemic Palliative Care (GCSPC) stated that the most common application for radiofrequency ablation is the treatment of pain in the spine, which has been used since the 1970s. There are many other applications, although these are two examples of the typical type of pain that this device is used to relieve. Rising prevalence of cancer is expected to drive growth of the global radiofrequency ablation device market during the forecast period. The number of cancer cases has increased over the years globally. According to the World Health Organization (WHO), in 2018, around 18.1 million new cases of cancer and 9.6 million deaths due to cancer were reported globally. According to the same source, around 70% of deaths from cancer occur in emerging economies with lung cancer accounting for the majority of deaths followed by breast cancer. Furthermore, according to the National Cancer Institute, in 2020, around 1,806,590 new cases of cancer are expected to be diagnosed in the U.S. with over 600,000 people dying from this disease. Such high incidence of cancer has led to increased demand for radiofrequency ablation devices. Hence, these factors are expected to drive growth global radiofrequency ablation device market during the forecast period. Furthermore, rising prevalence of cardiovascular disease combined with increasing number of ablation procedures is expected to boost the global radiofrequency ablation device market growth over the forecast period. Read more @ https://coherentmarketinsights-blog.blogspot.com/2020/12/radiofrequency-ablation-device-market.html

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

Endoscopy is a procedure that has been developed to assist in the removal of endometriosis from the human body. Endoscopy is also being used to help in the treatment of gallstones, cholecystitis, and gastric reflux disease among a number of other conditions. The recent developments in this industry have been driven by changes in government regulation and legislation. The increase in the number of malignancies and the introduction of fiscal policy in the region has resulted in political will on the part of the governments to strengthen public health services. Rising product approval for endoscopy devices by regulatory authorities is expected to drive growth of the global endoscopic stricture management device market during the forecast period. For instance, in January 2020, Pentax Medical received the U.S. Food and Drug Administration (FDA) approval for its Imagina Endoscopy System, which will be used in performing gastrointestinal procedures, digital image enhancement system with Pentax i-Scan. This endoscopy machine is equipped with an LED touch-screen interface, which removes the need for periodic bulb replacement. Besides, it is far more cost-efficient than the GI endoscopy system such as video endoscopy. Thus. These factors are expected to drive growth of the global endoscopic stricture management device market during the forecast period. Furthermore, increasing incidence of bleeding during surgical procedures combined with growing number of endoscopic procedures is expected to boost the global endoscopic stricture management device market growth over the forecast period. However, the lack of skilled healthcare professionals to perform surgical procedures, especially in emerging economies combined with complications related to endoscopic procedures such as bleeding and infection is expected to hamper the global endoscopic stricture management device market growth over the forecast period. Read more @ https://coherentmarketinsights-blog.blogspot.com/2020/12/end

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

Enteral feeding devices technological advanced medical device used to deliver nutrition food directly to the stomach to the bedridden patient suffering from chronic diseases such as cancer and neurological disorder. The increase in the cases of malnutrition and premature birth cases around the globe is a prime factor driving growth of the enteral feeding devices market. Moreover, the growing prevalence of chronic diseases such as cancer and cardiovascular disease is another key factor fostering the market growth of the enteral feeding devices. According to the World Health Organization, cancer is the second leading cause of death globally and is responsible for an estimated 9.6 million deaths in 2018. Globally, about 1 in 6 deaths occur due to cancer. Around 70% of deaths from cancer occur in low- and middle-income countries. Furthermore, increasing global expenditure on the healthcare sector for improving the patient care is further projected to augment the growth of the enteral feeding devices market. From the geographical perspective, North America is projected to gain significant growth over the forecast period and this is attributed to the high presence of the geriatric population prone to chronic disease that leads to digestive ailments. Read more @ https://coherentmarketinsights-blog.blogspot.com/2020/12/enteral-feeding-devices-to-gain.html

Surgical drain cleaning equipment plays an integral part in ensuring maximum productivity in the healthcare industry. These devices are meant to evacuate fluid and prevent the buildup of air at the surgical site. This is done with the use of vacuum or wall suction. Majority of these devices use negative pressure therapy to drain fluid from the surgical site. Demand for such medical devices has increased at a rapid pace due to their various advantages which make them highly useful. Increasing prevalence of chronic diseases such as cancer, cardiovascular disease, and kidney disease is expected to drive growth of the global surgical drainage devices market during the forecast period. According to the World Health Organization (WHO), in 2018, around 9.6 million deaths were attributed to cancer across the globe. According to the same source, around 70% of deaths from cancer occur in emerging economies. Moreover, according to the WHO, around 17.9 million people die from cardiovascular diseases each year globally. According to the same source, in 2010, around 2.3-3.7 million people were suffering from end-stage kidney disease. These above-mentioned diseases require significant surgical procedures and hence, it is boosting the demand for surgical drainage devices. Read more @ https://coherentmarketinsights-blog.blogspot.com/2020/12/surgical-drainage-devices-market-is.html

"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.

"Medical Devices Survey 2013-2014: Market Trends, Marketing Spend and Sales Strategies in the Global Medical Devices Industry" is a new report by canadean that analyzes how medical devices industry supplier companies' media spend, marketing and sales strategies and practices, and business planning are set to change in 2013-2014.

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

Medical ceramics are ceramics that have the properties to be used as the direct medium of medical procedures. They are made from a number of different materials including porcelain, enamel, ceramic, polymers, and other materials. The ceramic material is used to serve the purpose of impregnating the substances on the affected part so that they get affected by the required heat and are changed into a non-toxic and safe substance. Increasing demand for implantable devices is expected to drive the growth of the global medical ceramics market. The demand for implantable devices offer additional advantages including the ability to selectively activate grouping of fibers within the nerve. Major companies operating in the market are focused on research and development activities, in order to gain a significant edge in the competition. For instance, in December 2020, W. L. Gore and Associates, Inc. received the U.S. Food and Drug Administration (FDA) approval for its Gore Excluder Comfortable (EXCC) AAA Endoprosthesis to treat patients with aneurysm of the infrarenal abdominal aorta. Read more @ https://coherentmarketinsights-blog.blogspot.com/2021/02/medical-ceramics-market-is-expanding.html

PET-CT Scanner devices are highly advanced devices that help physicians make a correct diagnosis of the disease earlier, reducing unnecessary suffering to patients. They are widely used in a number of applications in the healthcare industry. One such medical application is in the field of diagnosing certain diseases, wherein the scanning of the body tissues, the positron emission tomography or PET-CT is used as a diagnostic tool. By using the ionization technique, scientists are able to locate and map the location of the abnormalities in a patient's body. This technology is a boon to mankind as it has helped in reducing the number of deaths caused by various diseases due to their early detection. The growing prevalence of cancer, HIV, and cardiovascular disease is driving the PET-CT scanner device market growth. Out of these chronic diseases, cancer held the highest share in the market. According to the World Health Organization, cancer is the second leading cause of death globally and is responsible for an estimated 9.6 million deaths in 2018. Globally, about 1 in 6 deaths is due to cancer. According to the U.S. Department of Health & Human Services, an estimated 36,400 new HIV infections occurred in the United States in 2018. Read more @ https://coherentmarketinsights-blog.blogspot.com/2020/12/pet-ct-scanner-devices-gaining-traction.html

Patient monitoring refers to the collection and analysis of medical data from one or more health settings (such as in hospitals or doctor's offices) for use by health care providers and other professionals in order to detect changes in an individual's medical status and to provide treatment options as needed. In health care, patient monitoring is generally the measurement of one or more medical parameters over extended periods of time, usually at different health care settings (such as in doctor's offices or hospitals). Patient monitoring may be implemented in many different health care settings including primary care offices, emergency rooms, doctors' offices, nursing homes, private practices, and government agencies. Most patient monitoring systems contain software that collect and store medical data in a database that is accessible to multiple health care providers and to health care facilities. High prevalence of chronic disorders is expected to propel growth of the global remote patient monitoring devices market over the forecast period. For instance, according to the study, "Global and regional diabetes prevalence estimates for 2019 and projections for 2030 and 2045: Results from the International Diabetes Federation Diabetes Atlas, 9th edition", published in the journal Diabetes Research and Clinical Practice, in September 2019, 463 million people are expected to suffer from diabetes in 2019 worldwide and the number is expected to reach 578 million by 2030 and 700 million by 2045. Read More @ https://coherentmarketinsights-blog.blogspot.com/2020/11/high-prevalence-of-chronic-disorders-to.html

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

Rationale for Clinical Trial Regulations Clinical trials, as we all know, are carried out to test the efficacy of a new drug or device being developed for a specific condition or disease. Clinical trials are experiments that have a high degree of risk if they are not properly implemented. For this reason, it is necessary for regulatory bodies to regulate clinical trials. The core rationale for regulating the various stages of clinical trials is that human subjects, who are part of the research, have to be protected. These clinical trial regulations are legislated at all stages: local, State, national and international. Clinical trial regulations are in force in different countries of the world. Common clinical trial regulations are also made globally by the International Conference on Harmonization (ICH), which has the mandate of setting out good practices for clinical trial regulations for trials done in global cooperation. These regulations cover the administrative, procedural and ethical aspects of clinical trials. Briefly, these are the areas in which there are clinical trial regulations for each of these aspects of clinical trials: Administrative: The administrative aspects of clinical trial regulations pertain to the way the clinical trials are run, and the way they are tracked and monitored throughout their lifecycle. A clinical trial is usually monitored by a sponsoring company or a Contract Research Organization (CRO), which the former hires at times for reasons of convenience and cost cutting. Clinical trial regulations in this area is obviously of importance because if something goes wrong at any administrative stage; these can be rectified. Procedural: Procedural aspects of clinical trial regulations relate to ways by which subjects are chosen for a clinical trial. Proper care has to be taken to ensure that the subjects are appropriate for the clinical study, are from the prescribed age, geographical, demographic, racial and gender-related cl

Disposable syringes are designed for one-time use and is discarded in order to prevent the spreading of infection. It can be defined as a sterile cylindrical medical instrument with a hollow needle at the end. This device act as a pump that easily draws drugs from vials and delivers these drugs to the body. A syringe is used to deliver injectable drugs in the body through an intravenous route. The growing use of injectable drugs across the healthcare sector is predominantly fueling the market growth of disposable syringes. The rise in global healthcare expenditure is another key factor propelling the market growth of disposable syringes. According to the World Health Organization, global spending on health was US$ 7.8 trillion in 2017 or about 10% of GDP and $1,080 per capita - up from US$ 7.6 trillion in 2016. Moreover, the growing demand for self-injection devices & long-acting formulations is again propelling the market growth. Increasing spending on R&D of new drugs development coupled with the growing demand for biologics will further favor the market growth of disposable syringes. Furthermore, growing concerns regarding needle stick injuries and accidental infections are also expected to bolster the market growth of disposable syringes. Read more @ https://coherentmarketinsights-blog.blogspot.com/2020/11/increasing-spending-on-r-of-new.html

The patient registry software market is expected to witness a significant growth over the next five years. The reason for this is the ever-expanding focus on healthcare delivery, particularly in the non-clinical fields of patient care, education, prevention and public health. Patient safety is being continuously refined with the advent of new devices and applications in the clinical laboratories. Certain drivers are also behind the patient registry growth. These include adoption of EHR, creation of patient registries to track patient records, and greater use of electronic medical records (EMR) for post-marketing management. Increasing prevalence of cancer and other chronic disorders is expected to propel growth of the global patient registry software market. For instance, according to the study, "Global and regional diabetes prevalence estimates for 2019 and projections for 2030 and 2045: Results from the International Diabetes Federation Diabetes Atlas, 9th edition", published in the journal Diabetes Research and Clinical Practice, in September 2019, 463 million people are expected to suffer from diabetes in 2019 worldwide and the number is expected to reach 578 million by 2030 and 700 million by 2045. Read more @ https://coherentmarketinsights-blog.blogspot.com/2020/12/increasing-prevalence-of-cancer-and.html