Medical device companies continually assess potential risks to individuals in order to enhance safety and comply with regulatory requirements. Risk management in the context of ISO 14971 is an integrated process that not only includes teams in product development, quality, but also many other parts of...
for manual trigge-ring of ventilation with 30:2 resuscita-tion Oxygen cylinders Cylinders for up to 400 liters of mobile oxygen We fulfill your exact requirements with MEDUCORE Stan-dard as the modular element in the LIFE-BASE portable system. You can carry everything in just one hand. Be...
29which demonstrated a need for Human Factors Engineering (HFE) in healthcare design. There is currently an increase in the attention given to fixing the device rather than fixing the user.6As a result, Design processes and HFE approaches strive to ensure the efficient functioning of these devi...
1. it is designed and manufactured in accordance with GB150 "the Pressure Vessel", GB 8599 "The Technical Requirements of Large Steam Sterilizer Automatic Control Protocol", and TSG R0004 the "Safety and Technology Specification for Fixed Monitor Ves...
In this chapter, we address the legal environment and the additional requirements for medical device certification imposed by the new regulations. We go into detail on the definitions of what is a medical device and who is a manufacturer or economic operator for the purposes of the regulations. ...
-Multilanguage support: Chinese / English operating system, support for other languages according to user requirements,full screen Chinese and English annotation input-Imaging specification: B mode: grayscale mapping ≥ 20 files, pseudo color ≥ 6 files, noise suppression ≥ 5 files, frame ...
7)NIBP measurement mode: Manual / AUTO / STAT, storage for 2400-group NIBP data. 8)Connect to Central Monitoring System by WiFi. 9)Built-in large-capacity battery, meets the requirements of long-term operation. AC/DC, achieves uninterrupted monitorin...
It includes the SMEED Device, the Hard Case User Manual and All Accessories are included. The Device itself attaches to the patient stretcher, litter, carrying device. When not in use, the SMEED Special Medical Emergency Evacuation Device folds into a ...
For bulk order, we can OEM outter box, user manual, etc according to your requirement.Outer box dimension: Length: 80mm Width: 60mm Height: 52mmPacking info: 1 pc/box, 100 pcs/cartonTechnical Parameters: Display method: Color OLED display, four display di...
1. it is designed and manufactured in accordance with GB150 "the Pressure Vessel", GB 8599 "The Technical Requirements of Large Steam Sterilizer Automatic Control Protocol", and TSG R0004 the "Safety and Technology Specification for Fixed Monitor Vessels" ...