Experts in being partners
Cert3Global gives master, sharp and involved direction for clinical devices, diagnostics, biotech, drug, and other medical organizations. We are here to provide you with a variety of regulatory documents and cGMP advisory solutions. By delivering flexible, information-based services, we specialize in assisting our clients in reducing their costs and time to market. Our worldwide regulatory experts apply up-to-date and robust regulatory knowledge to support your product development and submission plans, with regulatory expertise spanning all sorts of products. We can uphold your business achievement, by applying our mastery of the medical care market and any remaining key business sectors.
Our Expertise
Regulatory Affairs
We offer a full range of regulatory services from the initial regulatory strategy right through to approval and the post market phase.
Clinical Regulatory Affairs
Receive CER assistance from a team that is led by previous notified body leadership and is extremely familiar with the regulations.
Quality Assurance
Whether you are looking for assistance with internal audits or to delegate the running of your entire quality management system, we can support.
Latest Insights
What We Can Do
EU CE Marking
UK CA Marking
USA FDA
MDR Planning & Execution
IVDR Planning & Execution
MDR Clinical Evaluation
IVDR Clinical Evidence
Medical Device Consultancy
Medical Device Regulatory Consultancy
What our clients are saying
“We consider a vendor relationship to be more than just the vendor providing a product; we look for vendors who are committed to product and customer service improvement. Cert 3 Global fit that requirement perfectly.”
Davidson
“Cert 3 Global support team has been a great asset. In the first instance, they helped us determine our data requirements, and since then they’ve always been available to help clarify and assist with any confusing compliance procedures. A top-quality vendor.”
John
“We have been consistently impressed with Cert 3 Global constant dedication to ensuring that our compliance needs are met. We would recommend them to any firm looking for a market abuse or best execution solution.”
Paul
“Cert 3 Global commitment to product development as regulation changes stands out amongst its competitors. With Cert 3 Global we are confident that we have a partner that will evolve as our requirements also evolve.”