The IFU medical devices template is an MS Word document that contains all mandatory elements to create your own Information For Use (IFU) for medical devices. You can use the template to create an IFU that complies with the CE marking requirements, the Medical Device Regulation (EU) 2017/745...
For facility site movement, some documents should be submitted including the upgraded quality management system, the new performance evaluation data at the new site, and the upgraded IFU and label template, etc. China Med Device will help our clients comply with China regulations during your post-...
“During the transition period, as long as no EURL has yet been designated for that specific device, category or group of device, the notified bodies may accept applications for a class D IVD and issue the corresponding certificate(s).” When the class D device is re-certified after expiry ...
ISO 15223-1, Reference 5.1.1 Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirements. Manufacturer Indicates the medical device manufacturer. ISO 15223-1, Reference 5.1.2 Medical devices — Symbols to be used wit...
Through a partnership between a non-profit data institute and a medical device manufacturer, information on implantable embolization coils’ use was extracted, linked, and analyzed from clinical data housed in an electronic data warehouse from the state of Indiana’s largest health system. To evaluate...
(updated in March 2023). Some documents like the IFU and Technical Summary will need to be in Vietnamese while others like the Letter of Authorization will need to be Legalized. Eventually, manufacturers will need to submit their application in the Common Submission Dossier Template (CSDT) ...
1 Large Fragment Reduction Device - 2 Forceps with T handle - 3 Sharp Bone Hook - 4 Polyaxial Screwdriver (Hexagonal) 2.5 5 Hexagonal Screwdriver 3.5 6 Screwdriver with Sleeve 2.5 7 Bending Template (Straight) - 8 Bending Template (Curved) - 9 Pelvis Reduction Forceps (Straight with Angled ...
Infectious unit (ifu/mL)=Number of positive cells in the field×Number of fields in each well/(Virus volume (mL)×Dilution factor) The results show that after concentration of the purified recombinant adenovirus, the infection titer can reach above 1.0×1010ifu/mL. ...
A system by which resource information relating to an insertable medical device, such as an intravascular catheter, can be identified by its source so as to be accessed by a practit
A system for identifying and tracking a plurality of implant devices. The system includes at least one communication device and a medical implant device tracking system. The medical