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Unraveling the relationship between EN ISO 149711 and GSPR Unraveling the relationship between EN ISO 149711 and GSPR
City:Kuala Lumpur, Kuala Lumpur, Malaysia Malaysia
Category:Services (Health, beauty)
Date:7/26/2023 10:08:27 AM (422 days ago)
Description:The interrelationship between EN ISO 14971:2019/A11:2021 and the General Safety and Performance Requirements of Regulation holds great significance for device manufacturers in the EU. Collaborating...
EUDAMED - European Database on Medical DevicesEUDAMED - European Database on Medical Devices
City:Kuala Lumpur, Kuala Lumpur, Malaysia Malaysia
Category:Services (Health, beauty)
Date:7/18/2023 8:44:44 AM (430 days ago)
Description:However, the new medical devices regulations (EU MDR) contain important improvements including a much larger EUDAMED database. The new EUDAMED will be multipurpose. It will function as a registrati...
Regulatory Solution CE for In Vitro Diagnostic DeviceRegulatory Solution CE for In Vitro Diagnostic Device
City:Kuala Lumpur, Kuala Lumpur, Malaysia Malaysia
Category:Services (Health, beauty)
Date:6/14/2023 10:14:39 AM (464 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...
Overall Residual Risk - How to Evaluate it ?Overall Residual Risk - How to Evaluate it ?
City:Kuala Lumpur, Kuala Lumpur, Malaysia Malaysia
Category:Services (Health, beauty)
Date:6/19/2023 11:16:04 AM (459 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...
European Medical Device RegulationsEuropean Medical Device Regulations
City:Kuala Lumpur, Kuala Lumpur, Malaysia Malaysia
Category:Services (Health, beauty)
Date:6/23/2023 12:26:26 PM (455 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...
Clinical Development Plan Clinical Development Plan
City:Kuala Lumpur, Kuala Lumpur, Malaysia Malaysia
Category:Services (Health, beauty)
Date:7/13/2023 8:46:22 AM (435 days ago)
Description:A clinical development plan is a subpart of a clinical evaluation plan which aims at the devices which are going for clinical evaluation or the devices undergoing clinical investigations in the fut...
Responsibilities of a UK Responsible Person Responsibilities of a UK Responsible Person
City:Kuala Lumpur, Kuala Lumpur, Malaysia Malaysia
Category:Services (Health, beauty)
Date:5/30/2023 9:50:16 AM (479 days ago)
Description:We help you find the valid UK Responsible Person who is legally placed in UK market and help you getting UKCA mark. Definition of UK responsible person as per UK MDR 2019 is “ a person established ...
MHRA Registration to get UKCA Mark MHRA Registration to get UKCA Mark
City:Kuala Lumpur, Kuala Lumpur, Malaysia Malaysia
Category:Services (Health, beauty)
Date:6/2/2023 9:29:19 AM (476 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...
Prepare perfect Technical File for UKCA MarkPrepare perfect Technical File for UKCA Mark
City:Kuala Lumpur, Kuala Lumpur, Malaysia Malaysia
Category:Services (Health, beauty)
Date:6/6/2023 9:44:38 AM (472 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 ...
Stability Studies of Medical DevicesStability Studies of Medical Devices
City:Kuala Lumpur, Kuala Lumpur, Malaysia Malaysia
Category:Services (Health, beauty)
Date:6/8/2023 9:16:09 AM (470 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...
Medical Device Usability Testing Service providerMedical Device Usability Testing Service provider
City:Kuala Lumpur, Kuala Lumpur, Malaysia Malaysia
Category:Services (Health, beauty)
Date:6/9/2023 11:10:41 AM (469 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...
Design History File for Medical DevicesDesign History File for Medical Devices
City:Kuala Lumpur, Kuala Lumpur, Malaysia Malaysia
Category:Services (Health, beauty)
Date:6/13/2023 9:48:14 AM (465 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...
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