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Medical Devices Registration in BangladeshMedical Devices Registration in Bangladesh
City:Da Nang, Đà Nẵng, Vietnam Vietnam
Category:Services (Health, beauty)
Date:4/11/2024 1:51:18 PM (13 days ago)
Description:We help you to prepare Medical Device Technical File (MDR) as per the regulatory requirement of EU MDR 745/2017 and submit to notified body for review and approval of CE certification. In Banglades...
The Routes To Conformity - Navigating EU RegulationThe Routes To Conformity - Navigating EU Regulation
City:Da Nang, Đà Nẵng, Vietnam Vietnam
Category:Services (Health, beauty)
Date:3/29/2024 3:29:49 PM (26 days ago)
Description:Conformity Assessment Procedure for Medical Device under the Responsible Model (EU MDR 2017/745 & EU IVDR 2017/746). A medical device manufacturer has to follow Conformity Assessment Procedure befo...
Internal Quality Audit: Key Checks for SuccessInternal Quality Audit: Key Checks for Success
City:Da Nang, Đà Nẵng, Vietnam Vietnam
Category:Services (Health, beauty)
Date:3/4/2024 12:38:56 PM (51 days ago)
Description:To achieve and sustain excellence, a company needs a good quality control system. We provide Internal Quality Audit to helps organizations. Internal Quality audits are typically performed at predef...
Premium Organizational Management ServicesPremium Organizational Management Services
City:Đà Nẵng, Đà Nẵng, Vietnam Vietnam
Category:Services (Health, beauty)
Date:2/2/2024 5:20:04 AM (82 days ago)
Description:Take a premium advantage of MAVEN's Premium Organizational Management Services. These services are only for clients who are completely invested in making their plant highly compliant and are ready ...
Annual Maintenance Contract ServicesAnnual Maintenance Contract Services
City:Đà Nẵng, Đà Nẵng, Vietnam Vietnam
Category:Services (Health, beauty)
Date:11/28/2023 4:57:20 AM (148 days ago)
Description:We provide best AMC service where we take complete charge of ensuring regulatory compliance of all certifications held by the manufacturer. We acknowledge the limitations faced by such organization...
Classification of Medical Devices in VietnamClassification of Medical Devices in Vietnam
City:Đà Nẵng, Đà Nẵng, Vietnam Vietnam
Category:Services (Health, beauty)
Date:11/21/2023 3:08:47 PM (155 days ago)
Description:Medical devices in Vietnam are classified by CDSCO, Central Licensing Authority. Medical device other than in-vitro diagnostic medical devices are classified on basis of: Risk, Intended purpose, D...
What is a Clinical Evaluation Plan and Why is it Important?What is a Clinical Evaluation Plan and Why is it Important?
City:Đà Nẵng, Đà Nẵng, Vietnam Vietnam
Category:Services (Health, beauty)
Date:11/8/2023 6:12:44 AM (168 days ago)
Description:A Clinical Evaluation Plan is a document that outlines the systematic process of assessing the safety and performance of a medical device. It is a crucial component in the medical device industry a...
Design History File for Medical DevicesDesign History File for Medical Devices
City:Đà Nẵng, Đà Nẵng, Vietnam Vietnam
Category:Services (Health, beauty)
Date:11/8/2023 6:08:11 AM (168 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...
Clinical Development Plan Clinical Development Plan
City:Đà Nẵng, Đà Nẵng, Vietnam Vietnam
Category:Services (Health, beauty)
Date:11/8/2023 5:53:35 AM (168 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...
EUDAMED - European Database on Medical DevicesEUDAMED - European Database on Medical Devices
City:Đà Nẵng, Đà Nẵng, Vietnam Vietnam
Category:Services (Health, beauty)
Date:11/8/2023 5:52:36 AM (168 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...
MHRA Registration to get UKCA MarkMHRA Registration to get UKCA Mark
City:Đà Nẵng, Đà Nẵng, Vietnam Vietnam
Category:Services (Health, beauty)
Date:11/8/2023 5:51:37 AM (168 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...
Unraveling the relationship between EN ISO 149711 and GSPR Unraveling the relationship between EN ISO 149711 and GSPR
City:Đà Nẵng, Đà Nẵng, Vietnam Vietnam
Category:Services (Health, beauty)
Date:11/8/2023 5:51:13 AM (168 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...
Overall Residual Risk - How to Evaluate it ?Overall Residual Risk - How to Evaluate it ?
City:Đà Nẵng, Đà Nẵng, Vietnam Vietnam
Category:Services (Health, beauty)
Date:11/8/2023 5:49:52 AM (168 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...
CE Mark for Medical Devices: Stay AheadCE Mark for Medical Devices: Stay Ahead
City:Đà Nẵng, Đà Nẵng, Vietnam Vietnam
Category:Services (Health, beauty)
Date:7/28/2023 7:24:42 AM (271 days ago)
Description:The CE mark is of utmost importance in the European market, and understanding its intricacies is crucial for success. In this fast-paced and highly regulated industry, keeping up with the latest re...
European Medical Device Regulations European Medical Device Regulations
City:Đà Nẵng, Đà Nẵng, Vietnam Vietnam
Category:Services (Health, beauty)
Date:6/22/2023 6:07:39 AM (307 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...
Regulatory Compliance Solution CE for In Vitro Diagnostic DeRegulatory Compliance Solution CE for In Vitro Diagnostic De
City:Đà Nẵng, Đà Nẵng, Vietnam Vietnam
Category:Services (Health, beauty)
Date:6/14/2023 6:26:36 AM (315 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...
Medical Device Usability Testing Service providerMedical Device Usability Testing Service provider
City:Đà Nẵng, Đà Nẵng, Vietnam Vietnam
Category:Services (Health, beauty)
Date:6/9/2023 9:41:43 AM (320 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:Đà Nẵng, Đà Nẵng, Vietnam Vietnam
Category:Services (Health, beauty)
Date:6/8/2023 11:34:50 AM (321 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...
Responsibilities of a UK Responsible Person in UKResponsibilities of a UK Responsible Person in UK
City:Đà Nẵng, Đà Nẵng, Vietnam Vietnam
Category:Services (Health, beauty)
Date:5/29/2023 10:55:12 AM (331 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 ...
Prepare perfect Technical File for UKCA MarkPrepare perfect Technical File for UKCA Mark
City:Đà Nẵng, Đà Nẵng, Vietnam Vietnam
Category:Services (Health, beauty)
Date:6/5/2023 11:54:14 AM (324 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 ...
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