G&H | ITL
G&H | ITL provides end-to-end design and manufacturing services for medical devices, in-vitro diagnostics, and laboratory instruments.
Medical Device Regulatory Consulting
We accelerate regulatory approval and market introduction.
Our regulatory consulting services help you navigate the regulatory landscape and accelerate approval and market access for medical devices and IVDs.
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.
Startups and world-leading OEMs choose to partner with us for medical device regulatory consulting because of our knowledge, resources, certifications, and experience bringing compliant medical devices to market.
Capabilities
Achieving and maintaining CE Mark certification can be a complex process, but our experienced team can provide support at every stage, including Notified Body selection, device classification, performance evaluation, process validation, and preparation of all technical documentation.
As an FDA-registered medical device design manufacturer, 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.
If you are thinking about entering the Chinese market for the first time, trying to understand regulatory requirements can be overwhelming, and the system can be difficult to navigate. We’ll help you to understand the requirements before you begin the registration process. 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.
To distribute medical, diagnostic, or scientific devices in North America and Canada, you will require NRTL (Nationally Recognized Testing Laboratory) accreditation. We have a successful track record designing devices to meet the requirements, supporting customers throughout the accreditation process, including facility inspections.
Risk management is an integral part of medical device development and applies to every phase of the development lifecycle. We incorporate EN ISO 14971 requirements into our quality management system to provide a rigorous, risk-based approach to design and manufacturing while effectively demonstrating compliance within the scope of a project.
Our software design lifecycle is centered around IEC 62304 – the international standard for medical device software development. We can provide technical support and perform a gap analysis for all classes of embedded software and firmware.
IEC 62366 is the international standard for medical device usability analysis and development. Usability is an integral part of the development process because it ensures the safe and effective use of medical devices. We integrate usability engineering throughout design and development and can support usability testing for your device.
Safety and EMC (Electromagnetic Compatibility) has to be demonstrated for all electronic equipment and is an essential part of the CE marking process. We have a proven track record in delivering medical devices, in vitro diagnostic devices, and laboratory instruments that meet IEC 60601 and IEC 61010/IEC 61326 standards.
To market and sell a medical device in Europe, it will most likely need to bear the CE mark. Our experienced team can help you gain approval from your selected Notified Body by conducting a comprehensive technical file assessment to ensure all evidence is compliant with the regulatory requirements. We can also perform an independent gap analysis of your technical documentation, procedures, and processes to understand what steps you must follow to meet global regulatory requirements.
Regardless of whether your device is designed by a third-party design consultancy or by us, we have established procedures and considerable experience in transferring medical devices into manufacture. We perform pFMEA (process Failure Mode Effect Analysis) and Process Validation as part of the Design Transfer to ensure that your device can be manufactured repeatedly and effectively within our established processes. This process is typically performed collaboratively with our customers, as the resulting documentation is often required to support regulatory submissions.