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The growth of global market for portable medical electronic devices is hampered due to security concerns in the device, and connectivity problems. Introduction of home healthcare services, telemedicine facilities and nanotechnology has given rise to numerous opportunities for portable medical electronic devices market. The companies involved in medical device manufacturing are continuously concentrating on the development of cost effective medical devices. This report provides an in-depth analysis of key strategies adopted by key companies involved in this market.

The report also provides strategic conclusion for patents granted in last four years on portable medical devices. All prices in USD. Call us on U. To ensure high-level data integrity, accurate analysis, and impeccable forecasts. On-demand customization of scope of the report to exactly meet your needs. Targeted market view to provide pertinent information and save time of readers. Intravenous IV Ibuprofen Market.

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Medical devices that pertain to class I on condition they do not require sterilization or do not measure a function can be marketed purely by self-certification. The European classification depends on rules that involve the medical device's duration of body contact, invasive character, use of an energy source, effect on the central circulation or nervous system, diagnostic impact, or incorporation of a medicinal product. Certified medical devices should have the CE mark on the packaging, insert leaflets, etc.. These packagings should also show harmonised pictograms and EN standardised logos to indicate essential features such as instructions for use, expiry date, manufacturer, sterile, don't reuse, etc.

In November the Federal Administrative Court of Switzerland decided that the "Sympto" app, used to analyze a woman's menstrual cycle, was a medical device because it calculates a fertility window for each woman using personal data. The manufacturer, Sympto-Therm Foundation, argued that this was a didactic, not a medical process.

Medical devices excluding in vitro diagnostics in Japan are classified into four classes based on risk: [21].

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Classes I and II distinguish between extremely low and low risk devices. Classes III and IV, moderate and high risk respectively, are highly and specially controlled medical devices. In vitro diagnostics have three risk classifications. For the remaining regions in the world the risk classifications are generally similar to the United States, European Union, and Japan or are a variant combining two or more of the three countries' risk classifications.

Similarly to the EU classification, they rank in several categories, by order of increasing risk and associated required level of control. Various rules identify the device's category [23]. The Medical Devices Bureau of Health Canada recognizes four classes of medical devices based on the level of control necessary to assure the safety and effectiveness of the device. Class I devices present the lowest potential risk and do not require a licence.

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Class II devices require the manufacturer's declaration of device safety and effectiveness, whereas Class III and IV devices present a greater potential risk and are subject to in-depth scrutiny. Iran produces about 2, types of medical devices and medical supplies, such as appliances, dental supplies, disposable sterile medical items, laboratory machines, various biomaterials and dental implants. Some Iranian medical devices are produced according to the European Union standards.

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Some producers in Iran export medical devices and supplies which adhere to European Union standards to applicant countries, including 40 Asian and European countries. Some Iranian producers export their products to foreign countries. ISO is applicable to all providers and manufacturers of medical devices, components, contract services and distributors of medical devices.

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The standard is the basis for regulatory compliance in local markets, and most export markets. It requires that the development of manufactured products have an approval process and a set of rigorous quality standards and development records before the product is distributed. To meet the demands of these industry regulation standards, a growing number of medical device distributors are putting the complaint management process at the forefront of their quality management practices.

This approach further mitigates risks and increases visibility of quality issues. Starting in the late s [35] the FDA increased its involvement in reviewing the development of medical device software. The precipitant for change was a radiation therapy device Therac that overdosed patients because of software coding errors.


A study by Dr. Steven Nissen of the Cleveland Clinic , published in the Archives of Internal Medicine , showed that most medical devices recalled in the last five years for "serious health problems or death" had been previously approved by the FDA using the less stringent, and cheaper, k process. In a few cases the devices had been deemed so low-risk that they did not need FDA regulation. Of the devices recalled, 35 were for cardiovascular issues.

Diana Zuckerman , Paul Brown, and Dr. The aim of this program was to "develop a process that allows a single audit, or inspection to ensure the medical device regulatory requirements for all five countries are satisfied". A study published in in the Milbank Quarterly, a peer-reviewed policy journal, investigated whether studies reviewed by the FDA for high-risk medical devices are proven safe and effective for women, minorities, or patients over 65 years of age. The study determined that most high-risk medical devices are not tested and analyzed to ensure that they are safe and effective for all major demographic groups.

Therefore, they do not provide information about safety or effectiveness that would help patients and physicians make well informed decisions. In , an investigation involving journalists across 36 countries coordinated by the International Consortium of Investigative Journalists ICIJ prompted calls for reform in the United States, particularly around the k substantial equivalence process; [43] the investigation prompted similar calls in the UK and Europe Union.

Medical device packaging is highly regulated.

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Often medical devices and products are sterilized in the package. A series of special packaging tests measure the ability of the package to maintain sterility. Relevant standards include:. Package testing documents and ensures that packages meet regulations and end-use requirements. Manufacturing processes must be controlled and validated to ensure consistent performance. Medical device cleanliness has come under greater scrutiny since , when Sulzer Orthopedics recalled several thousand metal hip implants that contained a manufacturing residue.

This task group has issued two standards for permanent implants to date: 1. ASTM F Standard test method for extracting residue from metallic medical components and quantifying via gravimetric analysis [50] 2. Medical device manufacturing requires a level of process control according to the classification of the device. Higher risk; more controls. This means products can be more precision-engineered to for production to result in shorter lead times, tighter tolerances and more advanced specifications and prototypes. These days, with the aid of CAD or modelling platforms, the work is now much faster, and this can act also as a tool for strategic design generation as well as a marketing tool.

Failure to meet cost targets will lead to substantial losses for an organisation. The realisation of a new design can be very costly, especially with the shorter product life cycle. As technology advances, there is typically a level of quality, safety and reliability that increases exponentially with time. For example, initial models of the artificial cardiac pacemaker were external support devices that transmits pulses of electricity to the heart muscles via electrode leads on the chest.

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The electrodes contact the heart directly through the chest, allowing stimulation pulses to pass through the body.