- Quote: "A medical device is any device intended to be used for medical purposes."
Design, development, and manufacturing of devices used in the diagnosis, treatment, and monitoring of medical conditions.
Anatomy and Physiology: Anatomy and Physiology involves the study of the structure and function of the human body, enabling engineers and medical device experts to develop innovative and effective solutions that interact seamlessly with the human anatomy and physiology.
Biomaterials: Biomaterials refer to materials engineered to interact with biological systems, having applications in medical devices and technologies for repairing, replacing, or enhancing tissues and organs.
Biomechanics: Biomechanics is the study of mechanics, physics, and movement principles applied to biological systems, specifically analyzing the interactions between the human body and medical devices or engineering solutions.
Biosensors: Biosensors are devices that use biological elements to detect and measure various parameters in the surrounding environment, enabling accurate analysis and monitoring in fields such as healthcare, agriculture, and environmental science.
Imaging: Imaging refers to the process of creating visual representations or maps of internal structures, objects, or phenomena using various technologies and techniques, such as X-ray, ultrasound, magnetic resonance imaging (MRI), or computed tomography (CT).
Medical Robotics: Medical Robotics is the field of engineering and technology that involves the use of robotic systems in medical procedures and healthcare to enhance surgical precision and efficiency.
Regulatory Compliance: Regulatory compliance in Engineering and Technology and Medical Devices refers to adhering to laws, standards, and regulations set by governing bodies to ensure the safety, efficacy, and quality of the products and services provided.
Human Factors: Human Factors in Engineering and Technology and Medical Devices refers to the study of how humans interact with and are impacted by technology, with the aim of optimizing safety, efficiency, and user experience.
Biomedical Instrumentation: Biomedical Instrumentation involves the application of engineering principles and technology to develop instruments and devices used in medical diagnosis, monitoring, and treatment.
Quality Control: Quality control in the context of Engineering and Technology and Medical Devices refers to the process and systems implemented to ensure the reliability, safety, and effectiveness of products through various inspections, tests, and audits.
Biocompatibility: Biocompatibility refers to the ability of a medical device or material to interact with the human body without causing any harmful effects or triggering an immune response.
Clinical Research: Clinical research refers to investigation studies conducted on humans to evaluate the safety, efficacy, and effectiveness of medical devices or interventions for patient care and treatment.
Software and Data Analytics: Software and data analytics in Engineering and Technology and Medical Devices refers to the use of computer programs and data analysis techniques to interpret and gain insights from complex datasets, for the purpose of improving efficiency, accuracy, and decision-making in the development, operation, and maintenance of medical devices.
Signal Processing: Signal processing involves the manipulation and analysis of electronic or digital signals to extract meaningful information or enhance the quality of these signals for various applications in engineering and medical devices.
Wearable Medical Devices: Wearable medical devices are portable lifesaving instruments integrated into clothing or accessories that gather and transmit crucial health data for real-time monitoring and medical analysis.
Nanotechnology: Nanotechnology is the field that explores manipulating matter at the atomic and molecular level to create new materials and devices with exceptional properties for diverse applications in engineering, technology, and medical devices.
Rehabilitation Engineering: Rehabilitation Engineering involves the application of engineering principles and technology to design and develop assistive devices and systems that enhance the lives and capabilities of individuals with disabilities or impairments.
Medical Device Cybersecurity: Medical Device Cybersecurity refers to the protection of electronic devices and their associated data used in healthcare settings from unauthorized access, data breaches, and other cyber threats.
Diagnostic Medical Devices: Devices used to diagnose medical conditions, such as X-Ray machines, MRI scanners, CT scanners, and Ultrasound machines.
Therapeutic Medical Devices: Devices that are used to treat patients, such as pacemakers, insulin pumps, artificial organs, implantable cardioverter-defibrillators (ICDs), and neurostimulators.
Monitoring and Control Systems: Devices used to monitor and control medical conditions, such as blood glucose meters, blood pressure monitors, and oxygen tanks.
Implants: Devices that are implanted in the body, such as orthopedic implants, breast implants, and dental implants.
Prosthetics: Devices that are used as replacements for missing limbs or organs, such as prosthetic limbs and heart valves.
Assistive Devices: Devices used to assist people with disabilities, such as hearing aids, walking aids, and communication devices.
Laboratory Equipment: Devices used in medical laboratories to test samples, such as microscopes and centrifuges.
Personal Protective Equipment (PPE): Devices used to protect healthcare workers from injuries and infections, such as gloves, masks, and gowns.
Medical Software: Software used in healthcare settings to manage patient data, track medical records, and analyze medical conditions.
Rehabilitation Equipment: Devices used for post-surgical or post-traumatic rehabilitation, such as walkers, wheelchairs and physical therapy equipment.
- Quote: "Significant potential for hazards are inherent when using a device for medical purposes."
- Quote: "Medical devices must be proved safe and effective with reasonable assurance before regulating governments allow marketing of the device in their country."
- Quote: "As a general rule, as the associated risk of the device increases the amount of testing required to establish safety and efficacy also increases."
- Quote: "Discovery of what would be considered a medical device by modern standards dates as far back as c. 7000 BC in Baluchistan."
- Quote: "Study of archeology and Roman medical literature also indicate that many types of medical devices were in widespread use during the time of ancient Rome."
- Quote: "In the United States it was not until the Federal Food, Drug, and Cosmetic Act (FD&C Act) in 1938 that medical devices were regulated."
- Quote: "On May 26, 2017, the Medical Device Regulation (MDR) replaced the MDD."
- Quote: "Examples range from simple, low-risk devices such as tongue depressors, medical thermometers, disposable gloves, and bedpans."
- Quote: "One example of high-risk devices are those with embedded software such as pacemakers, and which assist in the conduct of medical testing, implants, and prostheses."
- Quote: "The global medical device market was estimated to be between $220 and US$250 billion in 2013."
- Quote: "The United States controls ~40% of the global market."
- Quote: "Japan has the second largest country market share."
- Quote: "The largest market shares in Europe (in order of market share size) belong to Germany, Italy, France, and the United Kingdom."
- Quote: "The rest of the world comprises regions like (in no particular order) Australia, Canada, China, India, and Iran."
- Quote: "The design of medical devices constitutes a major segment of the field of biomedical engineering."
- Quote: "Further, as associated risk increases the potential benefit to the patient must also increase."
- Quote: "Later in 1976, the Medical Device Amendments to the FD&C Act established medical device regulation and oversight as we know it today in the United States."
- Quote: "The largest market shares in Europe (in order of market share size) belong to Germany, Italy, France, and the United Kingdom."
- Quote: "One example of high-risk devices are those with embedded software such as pacemakers, and which assist in the conduct of medical testing, implants, and prostheses."