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Empowering MedTech Innovation with Compliance Excellence

Navigate the complexities of compliance with our expert guidance and risk management solutions.

SERVICES

QUALITY
MANAGEMENT

Tailored management system framework and solutions to drive intergrated product design and development, streamline operations and systematically meet your regulatory requirements.

REGULATORY
MANAGEMENT

Navigate global regulatory complexities and achieve market authorisation into multiple jurisdictions

OPERATIONS
MANAGEMENT

Solutions for optimising business operations, cross-functional communications and successful execution of go-to-market strategies

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Our Story

Eklego Consulting, founded by Natasha Nimalasiri, an expert in quality and regulatory affairs for Class I-III Sterile Medical Devices and SaMD, offers tailored compliance and risk management solutions. With deep experience in global regulatory landscapes, Natasha has enabled businesses in go-to-market strategies, operational excellence, and technical file development. Based in Sri Lanka, Eklego leverages APAC's talent to support global MedTech clients, fostering cross-border relationships and contributing to the region’s growing MedTech ecosystem.

For all your Medical Device Quality Assurance, Regulatory Affairs and Information Security Management needs

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