Services

We pride ourselves on our global regulatory intelligence. As part of our work to develop a global regulatory strategy for your device, we will help you understand the regulatory process, timelines, costs and nuances of country-specific requirements. Our experience spans the globe and we are eager to support your regulatory strategy in any country you wish to market in. We are also able to make recommendations for in-country regulatory support due to our many years of experience. If you are an international company entering the US Market for the first time, we can help you navigate the complexities of submissions and importing.

Our clinical team is led by a licensed physician assistant with direct experience in medical device clinical trials. From study design and protocol development to informed consent forms, case report forms, and IRB applications, we support every stage of the clinical process. When needed, we also prepare Investigational Device Exemption (IDE) submissions. Whether you need support managing a small clinical trial or coordinating with Clinical Research Organizations (CROs) for large-scale studies, we're equipped to help — from trial design through completion.

We specialize in building a regulatory strategy at the right moment — whether that's early in development or as your product design nears completion. An effective FDA strategy involves many critical decisions: when to engage FDA early, which regulatory pathway fits — 510(k), De Novo, or PMA — and identifying the right predicate device, applicable standards, and testing requirements, including whether clinical or animal studies are needed. As part of this process, we provide clear cost estimates and realistic timelines so you can plan with confidence.

Our team has 2 very experienced certified lead auditors who can take the strain off your organization by conducting your internal audits (FDA QMSR, ISO 13485, MDSAP). If you are not ready for an internal audit and are in the Quality Management System development stage, we can conduct a gap analysis to help you see clearly what is needed for a fully compliant QMS.

We are very experienced in preparation of Investigational Device Exemptions, 510Ks and deNovo applications. Our team will provide you with the list of documents required to prepare these submissions and work with you as you develop the documents to ensure they are complete and ready for FDA submission. We will stay engaged with you and the FDA throughout your device’s review process to see your device application through to a successful clearance.

Our team has experience in obtaining and maintaining a CE Mark under the EU Medical Device Regulation. If your device already has a legacy CE under the Medical Device Directive, we can support your transition to the MDR.

We coordinate and lead FDA pre-submission meetings to clarify expectations early, helping streamline your submission process and save time and resources.