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Medical devices include instruments, machines or implants used in medical care. Some, like X-ray machines or thermometers, diagnose diseases or conditions. Others, like pacemakers or inhalers, are used for prevention or treatment.
In the U.S., the government's Food and Drug Administration (FDA) must approve any device before it can be sold. The FDA also monitors safety for approved devices. If a device is defective or causes a health risk, the FDA can issue a recall.
If you use a medical device at home, make sure that you understand how to use it and follow the directions carefully.
Misonix Inc. (USA) - Designs, develops, and manufactures ultrasonic medical devices, scientific and industrial ultrasonic equipment, laboratory safety equipment, and air pollution control products.
Invivo Corporation - Designs, manufactures and markets sensor-based instruments for medical devices, safety equipment and industrial process control. (Nasdaq: SAFE).
SDCS - Consultant and advocate for the medical device industry on issues of regulatory and standards compliance, risk management (ISO 14971) and general device safety.
BesTech regulatory consulting - BesTech consulting services guides medical companies through the FDA and CE compliance processes to ensure their business success. We provide solutions for regulatory compliance, product safety, litigation support and design & development of medical devices.
ABC Fire & Safety Equipment Limited - Offer a wide range of products and services including fire equipment, first aid / medical supplies, emergency medical devices, fire extinguishers, automatic suppression systems,and industrial safety supplies from an office in Winnipeg, Manitoba.
IJP Electronics cc - South Africa. Manufactures variety of equipment for testing mechanical strength, electrical safety, heating capacity, and fire and insulation properties. Also produces device for relief of arthritic pain and other medical conditions.
AdviSolutions - Consulting on patient safety, quality improvement, and legal services. Includes medical device research, literature reviews, and links to related sites.
The CRO Group Inc. - Medical device, IVD, and biotechnology consulting in quality, regulatory, safety testing, clinical investigations, reimbursement, export, compliance, approvals, ISO9000, EN46000, ISO13485 certification, CE Marking, 21CFR820, 21CFR812, authorized representative, software-qa, mdr-vigilance, and ipo-venture capital audit preparations.
Medical Device Safety Service - European regulatory affairs company for ce mark and ISO services, an authorized european address, an authorized responsible person and authorized representative in the medical device industry.
Medical Device Resource Links - Information on medical equipment and trade, laws, regulations, and safety from around the world.