We have helped many companies navigate the complex world of medical devices
Cert3Global provides services for companies developing or manufacturing medical devices regulated under the United Kingdom (MHRA), United States Food and Drug Administration (US FDA), European Union Medical Device Regulation (EU MDR), and International Organization for Standardization (ISO). Our team has extensive experience working with these agencies and can assist you through the entire process of product development, premarket approval, post-market surveillance, and international marketing.
Our features of services
Regulatory Support Services – From initial concept to final submission, we will work closely with you to ensure your products are compliant with UK MHRA, US FDA, EU MDR, ISO standards, and any other applicable regulations.
Pre-Market Approval Assistance
Product Registration
Marketing Assistance
Compliance Consultation
Regulatory and Market Intelligence
Product Lifecycle Management
Clinical Trial Support
Compliance Assistance
Quality Assurance
Pre-market submissions
UDI Implementation
We understand how important it is to be able to rely on a single source for all your medical device needs. That is why we offer a variety of services that include
We work closely with you to ensure that your company meets the latest regulatory requirements, and that your products are compliant with them. Whether you need help with pre-market submissions, post-market follow-up, compliance assistance, technical files writing, or any other aspect of the medical device lifecycle, Cert3Global is here to assist you.
Contact Us Today!