The FDA and other regulatory bodies have detailed parameters¹ for what is considered a medical device, but a workable layman's definition might be: medical items used on or in a patient for treatment that are not purely drugs. Everything from syringes, wheelchairs, prosthetics, MRI machines, and heart valves to fullerene cages,² a nanotechnology structure so small it can cross the blood-brain barrier to deliver medication, are considered medical devices.
In 1994, a 3,500-year-old treatment was approved by the FDA to be marketed as a medical device. The ancient “medical device”? Leeches.³ Medicine has come full circle with regard to the benefits of the lowly leech, especially in connection with limb reattachment4 or certain reconstructive surgeries.
In medical device translation services, Class II and Class III medical devices, in particular, demand greater investment in the translation of associated documentation to mitigate risk. Because labeling is such an integral component of risk management in medical device use, obtaining a high-quality translation targeting the intended audience, e.g., patient, surgeon, or lab technician, is critical.
McElroy’s quality control measures for medical device translations ensure clients have the processes and verification needed to successfully manage risk and meet the stringent labeling and support documentation requirements of international regulatory agencies. McElroy’s medical device translation experience encompasses marketing and design collateral including datasheets, labels, package inserts, and websites, as well as patents, user manuals, and reports. McElroy will provide certificates of accuracy and information about our ISO-based workflow and processes upon request.
1 Is the Product a Medical Device?, Food & Drug Administration website.
2 Small Is Beautiful, Nanotechnology for Medical Devices, Jörg Vienken, Professor, BioSciences, Fresenius Medical Care, Germany.
3 FDA approves leeches as medical devices, Associated Press, 2004.
4 Modern Leeching, Bob Hirshon, Science Netlinks.