Medical Device
Biomedical Engineering · Last updated: July 30, 2026 · How this entry was written
Definition: An instrument, apparatus, machine, implant or software intended for diagnosis, monitoring, treatment or alleviation of disease, whose principal action is not achieved by pharmacological or metabolic means. In engineering practice it is a regulated product whose design, verification and manufacture must follow a controlled process.
Example in context
“Before the prototype could be sold, the team had to prove that the medical device met every essential safety and performance requirement in the technical file.”
“Prototip satılabilmeden önce ekip, tıbbi cihazın teknik dosyadaki tüm temel güvenlik ve performans gerekliliklerini karşıladığını kanıtlamak zorundaydı.”
Where engineers use it
Biomedical engineers use this term whenever they scope a product for regulatory submission, write design inputs, or plan verification testing. It defines which standards apply, so an engineer needs it to decide the required documentation, testing depth and market approval route.
Practice: can you use “Medical Device” at work?
A junior engineer must explain to a purchasing team why a new patient-monitoring cable counts as a medical device and what extra engineering evidence its release therefore requires.
Show a model answer
“This product is classified as a medical device, so design controls apply.”
“Medical Device” in 21 languages
| English | Medical Device |
|---|---|
| Turkish | Tıbbi Cihaz |
| French | Dispositif médical |
| German | Medizinprodukt |
| Spanish | Producto sanitario |
| Chinese | 医疗器械 |
| Arabic | جهاز طبي |
| Portuguese | Dispositivo médico |
| Russian | Медицинское изделие |
| Japanese | 医療機器 |
| Italian | Dispositivo medico |
| Vietnamese | Thiết bị y tế |
| Hindi | चिकित्सा उपकरण |
| Thai | เครื่องมือแพทย์ |
| Indonesian | Alat kesehatan |
| Korean | 의료기기 |
| Bengali | চিকিৎসা যন্ত্র |
| Dutch | Medisch hulpmiddel |
| Swedish | Medicinteknisk produkt |
| Finnish | Lääkinnällinen laite |
| Ukrainian | Медичний виріб |
Frequently asked questions
What does Medical Device mean in engineering?
An instrument, apparatus, machine, implant or software intended for diagnosis, monitoring, treatment or alleviation of disease, whose principal action is not achieved by pharmacological or metabolic means. In engineering practice it is a regulated product whose design, verification and manufacture must follow a controlled process. In Biomedical Engineering, the term carries a usage-frequency rating of 10/10 in the Engineering English library.
How do you pronounce Medical Device?
Medical Device is pronounced /ˈmedɪkl dɪˈvaɪs/ (IPA). The Engineering English app plays audio for the term and checks your pronunciation with speech recognition.
How is Medical Device used in a sentence?
Example from an engineering context: “Before the prototype could be sold, the team had to prove that the medical device met every essential safety and performance requirement in the technical file.”
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