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Course "Marketing Products without Getting Hammered by FDA" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: With this seminar you will learn how to navigate FDA's legal requirements and its interpretations for enforcement purposes. The agency now applies the principles of cognitive psychology to aid in its determination of what a message really conveys. This becomes a new factor in trying to stay within FDA's legal corral. This conference will provide insight on how to manage your marketing activity and gauge what regulatory risks your business is willing to accept. You will learn how corporate management requires cooperation between marketing, regulatory affairs, legal counsel, manufacturing, engineering and finance departments. You will understand that a weak link in any department leaves the entire corporation vulnerable to FDA enforcement. Most importantly, you will understand the boundaries that FDA uses and how easy it is to cross them. With information from this course, you can step back and rationally evaluate your firm's regulatory profile for advertising and promotion. Why should you attend: If you go "off label" with advertising and promotion, you become embroiled in FDA's advertising and promotion requirements. For devices, the law is weak and lacks legal clarity. For drugs, FDA's law and regulations are extensive and have violated Constitutional protections. Depending on your point of FDA's promotion and advertising requirements can help you or hurt you? There is an inherent conflict in interests. In any case, you need to identify practical criteria to make marketing decisions. That begs the question of whether or not marketing managers and regulatory affairs managers will even try to agree on an issue. FDA's Center for Devices and Radiological Health (CDRH) has never issued a comprehensive guidance on advertising and promotion. You are on your own. CDER has esta

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Tynor Abdominal Support Abdominal support is a compression belt to support the abdomen and compress the abdominal muscles. Its used as a post operative aid, by mothers after delivery and for waist line reduction. Pleasant aesthetics. Flexible sizing. Thin construction. Single panel of elastic. Tynor Abdominal Support Features Light weight and thin construction, does not peep through the clothes improves patient compliance. Extra porous webbing improves ventilation and comfort of the patient. Broad hook and loop tape panel offers better holding and size adjust-ability. Optimal compression, tones up abdominal muscles following surgery, CS or delivery. Special nylon reeves prevent rolling over of belt. Tynor Abdominal Support Measurements Abdominal Support 9 Measure circumference around the waist immediately below the navel.

Tynor Tummy Trimmer or Abdominal Belt Tummy Trimmer/Abdominal belt supports and compresses the abdominal muscles for waist line reduction and is used as a post operative or post delivery aid. Perfect elasticity. Breathable materials. Dermophillic. No rolling over, no buckling. Tynor Tummy Trimmer or Abdominal Belt Features Extra porous three panel webbing improves ventilation and comfort of the patient. Broad hook and loop tape panel offers better holding and size adjustability. Optimal compression, tones up abdominal muscles following surgery, CS or delivery. Optimal compression binds surgical incisions of abdomen & chest, improves healing. Holds the incision, provide analgesic effect during sudden movements or coughing. Special nylon reeves prevent rolling over of belt. Can be used in ventral hernia. Tynor Tummy Trimmer or Abdominal Belt Measurements Tummy Trimmer / Abdominal Belt 8 Measure circumference around the waist immediately below the navel.

Reclining Wheelchairs are specially designed to allow a person to comfortably recline at incremental angles safely and comfortably. Typically used for accommodation of severe hip extension contractures, or thostatic hypotension, and pressure re-distribution for prevention of skin breakdown. Recliner Wheelchairs work better with Elevating Legrests (ELRs); the user's legs and feet can also be re-positioned for maximum comfort and health benefits. The "ELRs" are optional on some models and standard on others. Be sure to ask about which type of ELR is best suitable for seating and position needs. On some wheelchairs this is an option so be sure to check the options and accessories when purchasing. Reclining Back Wheelchair( bed cum wheelchair ) which are suitable for indoor as well as outdoor purposes. These wheel chairs are manufactured using high quality material to ensure high strength and durability. Wheelchairs are available in foldable frames and are capable for maximum weight. Reclining wheelchairs are available in standard folding frames with extended head supports and seat widths up to 24" wide. The recline mechanism is attendant operated with levers much like a bicycle brake lever. The levers operate hydraulic (pump) mechanisms for a smooth adjustment. Using this reclining mechanism, the chair back can easily and frequently be positioned to any angle. Flexible Back Positioning: Reclining chairs offer unlimited back re-positioning for more patient comfort, better blood circulation, and to aid in sleeping. Work best with ELRs: Recliner chairs need Elevating Legrest so the patients legs and feet can also be re-positioned for maximum comfort. On some chairs this is an option so be sure to check the options and accessories section of each product page. Only the Back moves: On recliner wheelchairs the back reclines but the seat bottom stays in-place. Karma Aurora 4 Reclining Wheelchair: Frame Style : Fordable Frame Material : Aluminium (

Pediatric wheelchairs enable child or teen to participate in all types of daily activities. Pediatric wheelchairs are lightweight, portable, and convenient for use at school, day programs, doctor visits, and recreation with family and friends. Pediatric wheelchairs comes in wide range of sizes and vibrant colors for every lightweight wheelchair. A variety of positioning options are also available. Pediatric wheelchairs are manufactured with unsurpassed quality and style, specializing in compact-folding, lightweight wheelchairs for children of all ages - from toddlers to teens! Custom built to child's specific needs, mobility aids offer rehabilitative benefits for physical disabilities from Cerebral Palsy to Autism. Pediatric, or child wheelchairs, are mobile aids designed for and used by children. Children require the use of a wheelchair for many different reasons, some may have suffered head injuries, some have muscular dystrophy or cerebral palsy, some are amputees, and others only have an occasional use of their wheelchairs in lieu of a walking device or crutches. Certain types of pediatric wheelchairs are built to expand in size to accommodate increased bulk and weight by altering a cross balance on the bottom of the chair. The front frames for the legs can be lengthened as child's legs grow longer. For a pediatrician seeking to prescribe a Pediatric Wheelchair, must be sure that the patient has the proper upper body strength to use one. If the patient is too weak for self movement, the practitioner would be better to consider a powered wheelchair for mobility. While Pediatric Wheelchairs are smaller and can be just as manuverable as scooters, that depends upon the patient's own abilities in steering the chair. These are factors that the doctor must think about before recommending what type of wheelchair a patient should get. Pediatric Wheelchair with a body contouring S-Shaped seat frame and contoured armrests provides the user with all day comfort an

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Utilizing small wheels and lighter materials, transport wheelchairs can tip the scale at as little as 19 lbs., ideal for those looking for a highly portable option. Transport chairs also tend to be more affordable and offer the benefit of increased mobility without breaking the bank. This type of lightweight wheelchair is often referred to as a "transfer chair" and is typically used for shorter trips. Since it's geared towards storability and portability, it features four smaller wheels and dispenses with the larger, rear-mounted wheels that characterize standard wheelchairs. Its construction ensures that it's always foldable and portable, but does so at the expense of self-propulsion. Instead, a transport chair is built so that a caregiver can easily push the user from point A to B. Transport Wheelchair features a lightweight aluminum frame with a multiple finish options. It comes standard with padded-permanent armrests and swing-away footrests with composite footplates. It is an ideal solution for easy transportation and storage. Karma KM 2500 Small Wheel Wheelchair: Karma KM 2500 Small Wheel Wheelchair Specifications: Width 18" Front/Rear Wheels 6" to 14" Seat Width 47cm Seat Depth 40cm Overall Width 66cm Overall Collapsed Width 36cm Armrest Height 21cm Overall Length 90cm Seat Height 47cm Backrest Height 38cm Overall Height 86cm Weight 9.2 k.g. Karma KM 2500 Small Wheel Wheelchair Seat and Back: AEGIS Microbe Shield Approved by the FDA, EPA, EU, etc., bonded anti-microbial barrier upholstery protects from odor, staining and deterioration from bacteria, fungus and other microorganisms. It is a shield for your health. Karma KM 2500 Small Wheel Wheelchair Extended Armrest: By simulating the natural position of arms, the extended armrest design is ergonomic and creates bigger seating space. An Ultra lightweight wheelchair (9.2 kg) with a compact design for either attendant assisted or self propelling users. The

Hip Cycle is a stationary regular cycle exerciser used in physical therapy and as a sports fitness aid. Cycling is a low-impact exercise to increase muscle strength and mobility of the hips and knees. Cycling assists in hip toning by muscle growth and burning of calories. Hip Cycle Features Pedaling uses thigh muscles: quadriceps to push down, and hamstrings to pull up during the circular motion Cycling workout results in isometric engagement of the abdomen as a supporting muscle group Range of motion exercises help improve joint function Reduce hip pain caused by bone diseases such as osteoarthritis and necrosis Hip Cycle can be used in preferably recumbent position or in sitting position

Portable wheelchairs are easy to push, they fold to make them easier to store and simple for a friend or relative to load into a car. A wide selection of accessories too. So customize chair to give the performance, portability, comfort and style. Lightweight portable wheelchair are designed for ease of use and are made from durable material. These wheelchair are often fold able and are easier to store than conventional or custom. They are perfect for both manual and electric wheelchairs, as well as many walking aids such as a 4 wheel scooter. Lightweight portable wheelchair are extremely lightweight and for this reason they are easier to transport and store than many other types of wheelchair. Lightweight portable are made to be ultra lightweight, compact, and user friendly. They fold up in interesting ways to collapse to the size of a suitcase when not in use and are usually large enough to cover one or two stairs when extended. It is important to consider their weight and the person who would most often be carrying the ramp and setting it up. Types of Portable Wheelchair Ramps : Single Fold Ramps Trifold Wheelchair Ramps Multi Fold Ramps Transitional Ramps Advantage Suitcase Ramps Karma KM 2500 L Big Wheel Wheelchair Karma KM 2500 L Wheelchair Specifications Width 18" Front/Rear Wheels 6" to 22" Seat Width 47cm Seat Depth 40cm Overall Width 66cm Overall Collapsed Width 36cm Armrest Height 21cm Overall Length 90cm Seat Height 47cm Backrest Height 38cm Overall Height 86cm Weight 11.kg Karma KM 2500 L Wheelchair Seat and Back AEGIS Microbe Shield Approved by the FDA, EPA, EU, etc., bonded anti-microbial barrier upholstery protects from odor, staining and deterioration from bacteria, fungus and other microorganisms. It is a shield for your health. Karma KM 2500 L Wheelchair Extended Armrest By simulating the natural position of arms, the extended armrest design is ergonomic and creates bigger seating space. An Ult

Travel Wheelchair is ideal for those looking for an easily portable wheelchair without sacrificing sturdiness or weight capacity. In order to accommodate various heights, models feature adjustable backs and the threaded seat screw inserts reduce stripping from upholstery damage to give the chair a longer life. The wheels feature sealed bearings to keep dirt out, making the wheels virtually maintenance free. The Travel Chair is a lightweight sturdy aluminum framed portable chair. It is easily transportable and comes with a compact carry bag, making it ideal for stowing away in cars, buses, trains, and more. This wheelchair can be used both indoors and outdoors on forgiving terrain, with a convenient step for the attendant to lift the chair over obstacles. This travel chair gives the freedom to go, with the added convenience of folding up to a manageable size. This lightweight Steel Travel Chair with Fixed Full Arms or Detachable Desk Arms has a foldable back, making it convenient and easy to store and transport. The silver vein frame is scratch resistant and it comes standard with a comfortable, durable, and easy to clean, black nylon upholstery seat and back. The caster wheels in front and rear with provide a smooth ride over most surfaces. The padded armrests, rear wheel locks, swing away footrest and seat belt all combine to make this travel chair convenient, durable, easy to transport and safe. Karma Travel Wheelchair KM TV 20.2 Karma Travel Wheelchair KM TV 20.2 - 606 T-6 aircraft-grade aluminum-alloy frame provides incredible strength. Easy-to-fold in three seconds. Karma Travel Wheelchair KM TV 20.2 Features Type: Travel Wheelchair T-6 aircraft-grade aluminum Secure brake improve safety Padded flip back armrest PU front caster & rear wheel Karma Travel Wheelchair KM TV 20.2 Measurements Weight: 8.9kg Seat width: 39.5cm Tyre: PU front casters and rear wheels Capacity: 100kg Folded size: (L/W/H): 610mm x 350mm x710mm. Lightweight wh

Wheelchairs are easy to push, they fold to make them easier to store and simple for a friend or relative to load into a car. A wide selection of accessories too. So customise chair to give the performance, portability, comfort and style. Lightweight portable wheelchair are designed for ease of use and are made from durable material. These wheelchair are often foldable and are easier to store than conventional or custom. They are perfect for both manual and electric wheelchairs, as well as many walking aids such as a 4 wheel scooter. Lightweight portable wheelchair are extremely lightweight and for this reason they are easier to transport and store than many other types of wheelchair. Lightweight portable are made to be ultra lightweight, compact, and user friendly. They fold up in interesting ways to collapse to the size of a suitcase when not in use and are usually large enough to cover one or two stairs when extended. It is important to consider their weight and the person who would most often be carrying the ramp and setting it up. Karma KM 2500 Small Wheel Wheelchair: Karma KM 2500 Small Wheel Wheelchair Specifications: Width 18" Front/Rear Wheels 6" to 14" Seat Width 47cm Seat Depth 40cm Overall Width 66cm Overall Collapsed Width 36cm Armrest Height 21cm Overall Length 90cm Seat Height 47cm Backrest Height 38cm Overall Height 86cm Weight 9.2 k.g. Karma KM 2500 Small Wheel Wheelchair Seat and Back: AEGIS Microbe Shield Approved by the FDA, EPA, EU, etc., bonded anti-microbial barrier upholstery protects from odor, staining and deterioration from bacteria, fungus and other microorganisms. It is a shield for your health. Karma KM 2500 Small Wheel Wheelchair Extended Armrest: By simulating the natural position of arms, the extended armrest design is ergonomic and creates bigger seating space. An Ultra lightweight wheelchair (9.2 kg) with a compact design for either attendant assisted or self propelling users. The use

Tynor Leg Traction Brace is basically designed to provide traction to the leg. It works well even on the weak or geriatric skin. It ensures proper compression of the leg and provides traction. It is made of three layered polyurethane fabric which makes it soft and comfortable to use. The innermost layer gives the required friction for faster recovery. It is augmented with hook and loop closures to make it convenient to put on and remove. It does not require any adhesion. It provides cushion like support to the leg and relieves it from pain. It also prevents the bone from getting fractured and any muscle pull. It does not cause any peeling of skin and any rash or allergy on skin. It distributes the pressure exerted on the leg evenly. Tynor Leg Traction Brace Leg traction brace is a traction halter applied to the leg for below knee traction. It offers a distinct advantage of a very large holding surface area, ease of application and removal, reuse and patient comfort. Easy application & removal. Can be used for geriatric/ weak skin. Ideal for sensitive skins. Easy monitoring. Distributes pressure evenly. Tynor Leg Traction Brace Features Three-layered PU bonded fabric offers: Soft feel and plush looks through the top layer. Comfortable cushioning through the middle Polyurethane layer. Inner layer provides good frictional characteristics. Multiple hook loop closures Ensure controlled compression. Easy application and removal No loosening, less monitoring Large skin contact area Ensures no vaso-constriction. Eliminates need of an adhesive. Convenient and quick to apply Ensures no skin peeling. Ideal for weak or geriatric skins Tynor Rib Belt Rib belt is applied to the thoracic and upper abdominal region to compress and bind the rib cage during rib fractures and postoperative care, while allowing sufficient flexibility for comfortable breathing. Extra porous. With splinting pad. No buckling or rolling over. Controlled compression

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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

Cone beam computed tomography is an imaging technique that consists of X-ray computed imaging where the X-rays reflect and diverge, creating a cone-shaped beam. The cones are formed as the rays are deflected by colliding with a mirror and the resulting image is viewed from the inside of the cone. Cone-beam computed imaging uses the power of a computer to create images using the principle of diffraction and is very efficient in obtaining high quality images. Increasing prevalence of dental disorders is expected to propel growth of the global cone beam computed tomography (CBCT) market. For instance, according to the Centers for Diseases Control and Prevention's Oral Health Surveillance Report, 2019, the prevalence of untreated tooth decay in primary teeth was 10% among children aged 2-5 years and 16% among those 6-8 years during 2011-2016. Moreover, approval and launch of new products is also expected to aid in growth of the market. For instance, in December 2018, EhmetDX, received FDA 510(k) clearance for its 3D CBCT positioning software. The software is used to guide the position of proton beams in patient treatments. Increasing geriatric population is expected to offer lucrative growth opportunities for players in the global cone beam computed tomography (CBCT) market. For instance, according to the U.S. Census Bureau, the U.S. geriatric population is expected to reach 77 million by 2034. Read more @ https://sachinbhombe.blogspot.com/2021/03/increasing-prevalence-of-dental.html

Dementia is one of the most common age-related medical conditions. As we age, mental processes and memory become affected by changes in the brain, resulting in problems with memory, attention, mood, and behavior. Dementia can occur in anyone, although it is more common in elderly adults and people suffering from other mental disorders such as depression, bipolar disorder, schizophrenia, obsessive-compulsive disorder, and post-traumatic stress disorder. High prevalence of dementia is expected to propel growth of the dementia drugs market. For instance, according to Alzheimer's Association, around 5.8 million people in the U.S. aged 65 and older are living with Alzheimer's dementia in 2020. 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. Read more @ https://sachinbhombe.blogspot.com/2021/03/high-prevalence-of-dementia-and-r-of.html

Fungicides are biological active substances or biocides that kill specific fungal species or fungi. A fungicide restricts their proliferation. Fungi are known to cause serious economic damages in agriculture, causing financial losses, quality, and crop loss. Increasing demand for food is expected to propel growth of the seed treatment fungicides market. For instance, according to Food and Agriculture Organization, Asia Pacific needs to increase their food production by up to 77% by 2050 to meet food demand of increasing population. Moreover, decrease in arable land is also expected to aid in growth of the market. For instance, according to the study 'Will Limited Land, Water, and Energy Control Human Population Numbers in the Future', published in the journal Human Ecology, the amount of arable land available per person will decrease to 1500m² by 2050 from 4000m² in 1961. Approval of new pesticides and fungicides is expected to offer lucrative growth opportunities for players in the seed treatment fungicides market. For instance, in December 2019, The U.S. Environmental Protection Agency approved the use of 10 pesticide products on hemp in time for the 2020 growing season, which include nine Biopesticides, under the Federal Insecticide, Fungicide and Rodenticide Act. Read more @ https://coherentmarketinsights-blog.blogspot.com/2021/03/increasing-demand-for-food-and-approval.html

Nutricosmetics refers to nutritional supplements that are used to enhance aesthetic appeal. Skin care usually includes the application of creams, lotions and other skin products. Nutricosmetics can be used to make skin look younger and healthier. The ingredients used to make these products usually include vitamins, antioxidants, and other nutrients that the skin needs to function properly. There are other forms that can be used in making the skin look younger. Increasing aesthetic appeal is expected to propel growth of the nutricosmetics market. For instance, according to a 2018 survey by GlobalData, 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 nutricosmetics market. For instance, according to the U.S. Read more @ https://coherentmarketinsights-blog.blogspot.com/2021/03/increasing-aesthetic-appeal-and.html

High prevalence of gastric cancer is expected to propel growth of the gastric cancer therapeutics market. For instance, according to The American Cancer Society, the U.S. is estimated to record about 26,560 cases of stomach cancer and about 11,180 people will die from this type of cancer in 2021. Moreover, R&D in oral chemotherapy for the treatment of gastric cancer is also expected to aid in growth of the market. For instance, in January 2021, Ascelia Pharma AB announced the clinical development plan for Oncoral, with which the company has the opportunity to develop a novel oral chemotherapy for the treatment of gastric cancer. Risk factors for gastric cancer may include smoking and a diet of highly processed or salty foods. Thus, high number of smokers is expected to offer lucrative growth opportunities for players in the gastric cancer therapeutics market. For instance, according to the World Health Organization's, May 2020 Update, tobacco leads to over 8 million deaths each year worldwide and over 7 million of those deaths are the result of direct tobacco use while around 1.2 million are the result of non-smokers being exposed to second-hand smoke. Read more @ https://coherentmarketinsights-blog.blogspot.com/2021/01/high-prevalence-of-gastric-cancer-and.html