Our team specializes in delivering top-notch regulatory consulting services for medical device manufacturers worldwide. With a strong focus on compliance with EU, USA, and UK regulations, we ensure that our clients navigate the regulatory landscape with confidence.
About Our Company
Our Services
We provide regulatory compliance solutions for medical device and IVD companies, ensuring your products meet all necessary standards. Our expert team guides you through the intricate regulatory landscape, from initial development to market entry.
Resources
Stay informed with our informative blogs and updates on regulatory compliance and medical device certifications. Our content covers the latest industry trends, changes in regulations, and best practices. Click below button to read more about latest news and updates.
Our Services
Medical Device
We offer medical device regulatory consulting through compliance with FDA, and other global standards. Our services ensure your devices meet all regulatory requirements, expediting market entry.
Food & Supply
We offer comprehensive food registration services, ensuring compliance with FDA, USDA, and international regulations. Our expertise streamlines your registration process, facilitating smooth market entry.
Cosmetic & Toy
We offer cosmetic & toy registration services, ensuring compliance with FDA, CPSC, and international standards. Our streamlined process helps you achieve regulatory approval quickly and efficiently.
UKRP Services
We provide UKRP registration services, ensuring your medical devices comply with UK regulations post-Brexit. Our expertise simplifies the process, facilitating quick and efficient market access in the UK.
FDA 510k
We offer 510k clearance and approval services, guiding you through the regulatory process to ensure your medical devices meet all FDA requirements. Our expertise accelerates your path to approval.
Clinical Evaluation
We provide clinical evaluation services for medical devices, ensuring compliance with regulatory standards. Our thorough evaluations support your product’s safety, efficacy, and market approval.
We Solve MedTech Companies Regulatory Challenges!
We specialize in tackling the unique challenges faced by medical device manufacturers. Our comprehensive approach ensures compliance with stringent regulations, streamlining the certification process. By providing expert guidance and tailored solutions, we help you navigate complex requirements. Trust us to support your journey from development to market success with efficiency and expertise.
Our Core Team
Contact Us!
Ensure your business meets industry standards effortlessly. Contact us for expert regulatory compliance services. Your compliance, our priority. Stay ahead with our tailored solutions. Secure peace of mind today! Let us handle the complexities so you can focus on growth.
Testimonials
Michelle
We needed a trustworthy, expert service provider who could help us go through every regulatory check with professionalism and clarity. Right when Cert3global joined us,they helped us pass through every step and helped us know what exactly needed to improve our application by their experience and high-quality customer service.We recommend cert3global to every medical device…
Mr. John
Cert3global has been a great asset for our compliance procedures. Initially, they helped us determine our data requirements, and since then they have always been there at every step to help clarify and assist us with every compliance procedure. We can confidently say they are a top-quality, professional vendor who can be relied upon for…
Davidson
Cert3global’s commitment to product development and offering excellent customer service perfectly fit our requirements & expectations from a Vendor. Their professional team comprises experienced regulatory experts who bring in a much-needed regulatory angle at every step. With Cert3global by our side, we were able to navigate the complex regulatory landscape with confidence and achieve our…
Gerald
The best thing about Cert3Global was they customised their service according to our evolving requirements during the complete application process. Their emphasis on regulatory requirements at every step of product development makes them stand out amongst their competitors. Their diverse experience helped us to avoid pitfalls in advance, which would have stalled our application in…
Claudio Svalduz
Export Sales Administrator
Dear Luke, thank you very much for notifying us, your support to obtain this achievement was as usual just great, and we really appreciated it. Wish you a very good day.
Our Partners
ALS INTERNSATIONAL
