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Packaging Validation: Quality Assurance for Products 
(Bangkok)(Bangkok) - Services / Professional Services
Ensure your packaging meets standards with expert packaging validation. Trust us for reliable compliance every time. Packaging validation is a critical aspect of ensuring the safety and effectiveness ...
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Medical Devices Registration in Bangladesh
(Bangkok)(Bangkok) - Services / Professional Services
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 Bangladesh, ...
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Integrated Quality Management System: Your Complete Solution
(Bangkok)(Bangkok) - Services / Professional Services
Experience seamless quality control with our Integrated Quality Management System. Elevate efficiency and productivity effortlessly. The QMS requirements of the Canadian Medical Devices Regulations ar...
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Internal Quality Audit: Key Checks for Success
(Bangkok)(Bangkok) - Services / Professional Services
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 predefine...
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Turnkey Project: Leading Medical and IVD Device Consultancy
(Bangkok)(Bangkok) - Services / Professional Services
Maven Profcon Services LLP is a medical device consulting regulatory company provides regulatory guidance to medical device manufacturers in Ecuador. We help our clients by providing turnkey project s...
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Premium Organizational Management Services
(Bangkok)(Bangkok) - Services / Professional Services
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 to ...
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Deciphering MDCG Rules: Annex XVI Insights Revealed!
(Bangkok)(Bangkok) - Services / Professional Services
The newly proposed MDCG guidelines are a valuable resource for manufacturers (of products without an intended medical purpose), notified bodies, and stakeholders navigating the intricate landscape of ...
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Annual Maintenance Contract Services
(Bangkok)(Bangkok) - Services / Professional Services
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 organizations a...
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What is a Clinical Evaluation Plan and Why is it Important?
(Bangkok)(Bangkok) - Services / Health, Personal Trainer
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 as i...
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CE Mark for Medical Devices - Stay Ahead
(Bangkok)(Bangkok) - Services / Health, Personal Trainer
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 requi...
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Unraveling The Relationship Between EN ISO 149711 and GSPR of Regulation
(Bangkok)(Bangkok) - Services / Health, Personal Trainer
The interrelationship between EN ISO 14971:2019/A11:2021, Annex ZA, Annex ZB, and the General Safety and Performance Requirements of Regulation holds great significance for device manufacturers in the...
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EUDAMED - European Database on Medical Devices
(Bangkok)(Bangkok) - Services / Health, Personal Trainer
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 registration ...
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Clinical Development Plan (CDP)
(Bangkok)(Bangkok) - Services / Health, Personal Trainer
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 future...
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European Medical Device Regulations
(Bangkok)(Bangkok) - Services / Health, Personal Trainer
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 detaile...
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Overall Residual Risk - How to Evaluate it ?
(Bangkok)(Bangkok) - Services / Health, Personal Trainer
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 ack...
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Regulatory Compliance Solution CE for In Vitro Diagnostic Device
(Bangkok)(Bangkok) - Services / Health, Personal Trainer
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 IVDs...
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Design History File for Medical Devices
(Bangkok)(Bangkok) - Services / Health, Personal Trainer
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 13485:20...
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Medical Device Usability Testing Service provider
(Bangkok)(Bangkok) - Services / Health, Personal Trainer
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 Medical ...
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Stability Studies of Medical Devices
(Bangkok)(Bangkok) - Services / Health, Personal Trainer
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 de...
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Prepare perfect Technical File for UKCA Mark
(Bangkok)(Bangkok) - Services / Health, Personal Trainer
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 of ...
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MHRA Registration to get UKCA Mark for selling Medical devices
(Bangkok)(Bangkok) - Services / Health, Personal Trainer
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 re...
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Responsibilities of a UK Responsible Person in UK
(Bangkok)(Bangkok) - Services / Health, Personal Trainer
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 i...
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