Essays about: "CE-mark"

Found 5 essays containing the word CE-mark.

1. 1. ​​​Biological characterization of a novel biomaterial​​ : ​​In vitro studies of a biodegradable Mg-Ca alloy​

   University essay from Uppsala universitet/Institutionen för medicinsk cellbiologi

   Author : Emma Gonzales Vall; Alma Gårdman; [2023]
   Keywords : Mg-Ca alloy; biological evaluation; biocompatibility; biodegradable implant;

   Abstract : Biodegradable implants continue to be of interest in orthopaedics for their many potential applications. The magnesium (Mg) alloy WE43 is a biodegradable material with the CE mark approval for clinical application and today mostly used as screws for dental prosthesis. READ MORE

3. 2. CE marking of a lifting beam

   University essay from Högskolan Dalarna/Maskinteknik

   Author : Peter Mattias Pawel Huld; [2021]
   Keywords : Lifting beam; CE marking; Rotork; Rejlers;

   Abstract : Rotork is a company stationed in Falun municipality, Sweden and manufactures electric valve actuators. This thesis will investigate one of their lifting beams used in daily production. Although already being used for more than 10 years, it is still not yet CE market which is necessary for it to be used legally. READ MORE

4. 3. MDR 2017/745 - New EU Regulation for Medical Devices: A Process Description for EHR Manufacturers on How to Fulfill the Regulation

   University essay from KTH/Medicinteknik och hälsosystem

   Author : Frida Germundsson; Nicole Kvist; [2020]
   Keywords : MDR; regulation; process description; EHR system; CE mark; medical technology;

   Abstract : On the 26th of May 2021 the new regulation for medical devices, MDR 2017/745, will come into force. The underlying incentives to go from the medical device directive (MDD 93/42/EEC) to MDR are a series of adverse events involving medical devices. READ MORE

5. 4. Evaluating the Compliance Re-Certification Efficiency Enabled by the AMASS Platform for Medical Devices

   University essay from Mälardalens högskola/Akademin för innovation, design och teknik

   Author : Aleksandër Pulla; Antonela Bregu; [2020]
   Keywords : AMASS project; certification; re-certification; efficiency; medical devices; ISO 14971; NBRG Consensus paper; reuse; standard; tool-chain; metrics; directives; regulations;

   Abstract : The certification of systems in the medical domain aims to ensure that a system is acceptably safein order to bear the CE mark. Such process is exhaustive, expensive, time-consuming and safety-critical.Medical devices shall be re-certified under Medical Device Regulations. READ MORE

6. 5. Requirements specification for PressCise : A study of the material mechanical properties of the No.14001 bandage

   University essay from Högskolan i Borås/Institutionen Textilhögskolan

   Author : ANNA PEHRSSON; SOFIA LARSSON; [2014]
   Keywords : compression bandage; veracious veins; requirement specification; CE-mark; hysteresis test; washing test; abrasion test;

   Abstract : Varicose veins is a condition, which affects numerous people. The condition is mostly not harmful but aesthetically unappreciated. Therefore many people choose to have them surgically removed. After the surgery is completed, the leg is bandaged, this for creating an ideal healing environment, without any complications occurring. READ MORE