ABOUT US
MDDEV
MEDICAL TECHNOLOGY CONSULTANCY
MdDev Sdn Bhd is a company incorporated in Malaysia with a team of MedTech specialists over 25 years in various subject matters, expertise, providing technical consultation, medical technology training and project management in healthcare technology, medical devices and regulatory affairs.
OUR VISION
Our vision for MdDev is to build a world-class consulting firm driven by total commitment to excellent services and compliance to regulations set out by the world regulators.
OUR MISSION
MdDev aims to enable growth in people and organisations through effective knowledge empowerment and methodology application to achieve excellence in best practices within the medical technology sector.
OUR SERVICES
MEDICAL TECHNOLOGY PROJECT CONSULTANCY
We assist you with development of documentation for project proposal
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Medical device technical documentation based on WHO, IMDRF & Good Regulatory Practice(GRP)
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Hospital Support Services (standard operating procedures) based on international requirements
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Maintenance Management documentation for medical devices
MEDICAL DEVICE & IVD REGISTRATION
We assist you with specific medical device registration & follow up with the competent authority until issuance of registration certificate in Malaysia & ASEAN member states
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Classification of medical devices
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Development of technical documents for medical devices without premarket regulatory approvals
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Development of document for medical devices with premarket regulatory approvals
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Assist with MeDC@St2.0 online medical device registration application in Malaysia
ESTABLISHMENT LICENSE
We assist you with development of documentation for regulatory compliance in Malaysia & ASEAN member states
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Development of document for establishment license as authorised representative, distributor, importer
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Assist with MeDC@St 2.0 online establishment registration application in Malaysia
QUALITY MANAGEMENT SYSTEM
Customized development of documentation for quality assurance program in Malaysia & ASEAN member states
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ISO 13485:2016 specifies requirements for a quality management system for organizations involved in manufacturing medical devices
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Good distribution practice for medical devices (GDPMD) for Authorised representatives, Distributors, and Importers in the medical device supply chain.
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