Medical Devices
We provide regulatory consulting and compliance support for medical devices and IVDs across the United Kingdom, European Union, and United States.
Our services include support for Authorised Representative and Responsible Person roles, along with guidance on regulatory pathways, technical documentation, and market-specific requirements.
We support manufacturers in preparing for market entry and maintaining compliance through a structured, documentation-focused approach aligned with applicable regulatory frameworks.
Select your region
We provide medical device and IVD regulatory support across the United Kingdom, European Union, and United States.
Our services align with key regulatory frameworks, including EU MDR (2017/745), IVDR (2017/746), UK MDR 2002, and applicable US FDA requirements. We support manufacturers in understanding these frameworks and preparing documentation, processes, and submissions accordingly.
Whether you are entering a new market or managing compliance across multiple regions, our approach helps you navigate requirements clearly and prepare your products for regulatory review.
European Union
United Kingdom
United States
Global Medical Device Compliance – Beyond Borders
At Cert3Global, we support medical device and IVD manufacturers across the United Kingdom, European Union, and United States through structured regulatory consulting and compliance services.
We assist businesses in preparing for regulatory requirements in these markets, including documentation development, regulatory pathway planning, and coordination of key compliance processes such as Authorised Representative or US Agent roles.
Whether you are preparing for an initial market entry or expanding into additional regions, our approach focuses on clarity, accuracy, and practical implementation—supporting your regulatory strategy at each stage of the product lifecycle.
