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The key differences between MDR and IVDR in the EU The key differences between MDR and IVDR in the EU (Kuala Lumpur)(Kuala Lumpur) - Services / Professional Services
In the European Union (EU), two significant regulations have been introduced to enhance the safety and effectiveness of medical devices – the In Vitro Diagnostic Regulation (IVDR) and the Medical De...
IVDR's Summary of Safety and Performance: Your Essential Guide IVDR's Summary of Safety and Performance: Your Essential Guide (Kuala Lumpur)(Kuala Lumpur) - Services / Professional Services
Delve into IVDR's Summary of Safety and Performance for crucial insights and compliance essentials. Stay informed with our concise guide. The world of in vitro diagnostics is all about accuracy and re...
Packaging Validation: Quality Assurance for Products Packaging Validation: Quality Assurance for Products (Kuala Lumpur)(Kuala Lumpur) - 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 ...
Medical Devices Registration in Bangladesh Medical Devices Registration in Bangladesh (Kuala Lumpur)(Kuala Lumpur) - 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, ...
The Routes To Conformity - Navigating EU Regulation The Routes To Conformity - Navigating EU Regulation (Kuala Lumpur)(Kuala Lumpur) - Services / Professional Services
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 bef...
Integrated Quality Management System: Your Complete Solution Integrated Quality Management System: Your Complete Solution (Kuala Lumpur)(Kuala Lumpur) - 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...
Internal Quality Audit: Key Checks for Success Internal Quality Audit: Key Checks for Success (Kuala Lumpur)(Kuala Lumpur) - 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...
Turnkey Project: Leading Medical and IVD Device Consultancy Turnkey Project: Leading Medical and IVD Device Consultancy (Kuala Lumpur)(Kuala Lumpur) - 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...
Premium Organizational Management Services Premium Organizational Management Services (Kuala Lumpur)(Kuala Lumpur) - 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 ...
Deciphering MDCG Rules: Annex XVI Insights Revealed! Deciphering MDCG Rules: Annex XVI Insights Revealed! (Kuala Lumpur)(Kuala Lumpur) - 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 ...
Annual Maintenance Contract Services Annual Maintenance Contract Services (Kuala Lumpur)(Kuala Lumpur) - 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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