About Us

Our Core Competencies

A specialised hub for Medical Device Registration, Local Authorized Representative (LAR), Regulatory Affairs Training & Regulatory Intelligence.

Presaga Elite Consultancy SDN BHD is a leading professional consulting company, exclusively catering to businesses involved in the medical device sector.

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OUR MISSION

Driving Success in Cooperation and Excellence

Forging Success through Trusted Partnerships

We are the trusted partner for medical device businesses, specializing in regulatory compliance support. With dedication to excellence, we empower clients for success and foster long-term partnerships built on trust, integrity, and shared objectives.

Unveiling the Pinnacle of Service Excellence

Our unwavering dedication lies in delivering unparalleled service excellence through a wide spectrum of technical services and customized solutions that cater to the unique requirements of our esteemed clients. Our primary objective is to assist our clients in achieving regulatory compliance, ensuring utmost product safety, and fostering substantial business expansion.

OUR SERVICES

Medical Device Consulting Specialists

We are reputable consultants for ISO 13485, GDPMD, GMP and etc. As for Medical Laboratories we have expertise on consultancy for settting up Medical Laboratories and implementation of ISO 15189 standards.

Whether sourced domestically or imported, compliance with the local national regulatory authorities is essentials of medical devices to meet regulatory standards and be eligible for market placement.

Our organization boasts a wealth of expertise in the establishment and optimization of clinical laboratory setups. Through our comprehensive guidance, client can streamline their operation and ensure unwavering adherence to industry-leading standards.

With our dedicated team, you can confidently navigate the complexities of regulatory compliance while optimizing the efficiency and effectiveness of your clinical laboratory setup.

OUR SERVICES

Registration & Representation

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OUR SERVICES

Market Surveillance & Reporting

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LET'S COLLABORATE

Take the next step towards achieving remarkable success in the medical device industry.

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Our expert consulting services are tailored to propel your company forward. Streamline your regulatory processes, enhance product development, and ensure compliance with ease.