Delivering quality is important to us.

As technology and your needs evolve, so does our approach to quality. We continuously refine our Quality Management System to ensure our customers get the quality and reliability they deserve.


Quality Management System

We operate a comprehensive Quality Management System (QMS) to control design, development, and manufacturing processes for medical devices entering into worldwide markets.

Our robust QMS is certified to ISO 9001:2015 and ISO 13485:2016 and compliant to FDA 21 CFR Part 820 to ensure that all devices are fit for their intended purpose, meet the required specifications for quality and safety, and comply with national and international regulatory requirements.


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Quality you can count on.

ISO 9001 & ISO 13485

We are audited and accredited to ISO 9001:2015 and ISO 13485:2016. Our Quality Management System also incorporates ISO 14791, ISO 62304, and ISO 62366 standards to ensure a robust and fully compliant regulatory framework.

FDA 21 CFR Part 820

ITL has been an FDA-compliant medical device manufacturer since 1983. We have considerable experience supporting customers with FDA pre-market approval (PMA) and 510(k) applications, and de novo classification requests for US market access.


We are compliant with 2017/745 MDR and 2017/746 IVDR, enabling us to support the CE marking process for medical and in vitro diagnostic devices. We have the capabilities to design and manufacture Class I, IIa, IIb, and III medical devices and all classes of IVD medical devices.


As a contract manufacturer, it is not possible for G&H | ITL to be registered to MDSAP, however, our experienced regulatory consultants are able to provide support with all MDSAP activities and audits.


With in-country representation for medical devices, we have hands-on experience supporting customers with NMPA/CFDA approvals and have established strong partnerships with Clinical Research Organizations.

Our Certifications

Download or view our certificates.

Download our ISO 9001:2015 certificate
Download our ISO 13485:2016 certificate
View our FDA registration certificate

Medical Device Regulatory Consulting Services

We provide expert medical device regulatory consulting for every step of the product development lifecycle. Our global regulatory affairs team has decades of experience working with medical devices and in-vitro diagnostics of all classes and can help you gain access to European, North American, and Asian markets with speed and efficiency.