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European Medical Device RegulationsEuropean Medical Device Regulations
City:Hong Kong, Hong Kong (香港), Hong Kong Hong Kong
Category:Services (Health, beauty)
Date:6/27/2023 12:42:48 PM (365 days ago)
Description:It has been said that European Medical Device Regulations is the most significant change to the regulatory framework in the medical device industry since CE Marking was introduced in 1993. Get deta...
Overall Residual Risk - How to Evaluate it ?Overall Residual Risk - How to Evaluate it ?
City:Hong Kong, Hong Kong (香港), Hong Kong Hong Kong
Category:Services (Health, beauty)
Date:6/19/2023 5:01:10 AM (373 days ago)
Description:The risk management standard ISO 14971:2019 is the Holy Bible for medical device risk management. As elegant as it has been presented on its own, one could consider it as ISO’s tip of the hat to ac...
Regulatory Solution CE for In Vitro Diagnostic DeviceRegulatory Solution CE for In Vitro Diagnostic Device
City:Hong Kong, Hong Kong (香港), Hong Kong Hong Kong
Category:Services (Health, beauty)
Date:6/15/2023 4:42:15 AM (377 days ago)
Description:Get the EUDAMED registration done for IVD based on the regulations of EU 2017/746. We assist you get the CE for In-vitro Diagnostic Device CE Marking Service covering General IVDs, Self-testing IVD...
Design History File for Medical DevicesDesign History File for Medical Devices
City:Hong Kong, Hong Kong (香港), Hong Kong Hong Kong
Category:Services (Health, beauty)
Date:6/12/2023 9:54:00 AM (380 days ago)
Description:Get your Design History File planned and approval for your medical devices in Vietnam, Malaysia, Hong Kong and Thailand. Get complete assistance in creating DHF as per the requirements of ISO 13485...
Medical Device Usability Testing Service providerMedical Device Usability Testing Service provider
City:Honh Kong, Hong Kong (香港), Hong Kong Hong Kong
Category:Services (Health, beauty)
Date:6/10/2023 8:41:16 AM (382 days ago)
Description:We help you get done medical devices usability testing. We provide medical device usability testing and usability engineering services in Vietnam, Malaysia, Hong Kong and Thailand. Performing Medic...
Stability Studies of Medical DevicesStability Studies of Medical Devices
City:Hong Kong, Hong Kong (香港), Hong Kong Hong Kong
Category:Services (Health, beauty)
Date:6/8/2023 5:24:33 AM (384 days ago)
Description:Maven helps you to design a Stability Studies of Medical Devices Plan and reduce errors. The purpose of the Stability Studies of Medical Devices is to give information on how the quality of medical...
Prepare perfect Technical File for UKCA MarkPrepare perfect Technical File for UKCA Mark
City:Hong Kong, Hong Kong (香港), Hong Kong Hong Kong
Category:Services (Health, beauty)
Date:6/6/2023 11:36:38 AM (386 days ago)
Description:Our consultancy helps you in establishing your products in various countries with help of our experienced regulatory consultants. The content of the Technical File for UKCA Mark is similar to that ...
MHRA Registration to get UKCA Mark for selling Medical devicMHRA Registration to get UKCA Mark for selling Medical devic
City:Central Hong Kong, Hong Kong (香港), Hong Kong Hong Kong
Category:Services (Health, beauty)
Date:6/1/2023 11:28:44 AM (391 days ago)
Description:The MHRA Registration database contains manufacturer name, address, MHRA reference (account) number, all the devices registered by GMDN term. MHRA Registration must be renewed one year after your r...
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