REGULATORY
COMPLIANCES SOLUTIONS

We offer complete regulatory services to medical device manufacturers utilizing our multi-decade experience and competent team. Our Mission is to ensure your success in overcoming the challenges of today’s medical device landscape by providing top-notch services. We’re dedicated to providing comprehensive regulatory consulting services for medical device manufacturers globally.

Regulatory Experts

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What We Do

Cert3Global : Your Guide to Medical Device Compliance

At Cert3Global, we’re renowned for our 85% success rate, achieved through the expertise of our experienced and competent regulatory experts. 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.

Our commitment to honesty, integrity, and fairness is ingrained in everything we do. It’s this dedication that has earned us the trust and respect of our clients, making us a trusted name in the industry. With Cert3Global, you can rely on our proven track record and expert guidance to overcome regulatory challenges and achieve your business goals.

Impact of Brexit on the Medical Device Industry

There have been significant effects of Brexit on the medical device industry. As the United Kingdom is officially leaving the EU, a lot of manufacturers are aiming to get UKCA accreditation in the forthcoming years.

New Regulations

New regulations MDR 2017/745 for medical devices and IVDR 2017/746 for in vitro diagnostic devices pose compliance challenges. Cert3Global provides legal assistance to companies for swift compliance, even with limited in-house resources.

Cert3global’s promise

We offer thorough regulatory consulting services for medical devices, aiding in registration, providing 510(k) guidance, and acting as a US agent for various device types. Our commitment to success ensures reliable outcomes, while our transparent pricing maintains consistency throughout our services, fostering trust and confidence in our clients.

What is special with us and how we addressed medical device manufactures challenges!

Regulatory documentation and registrations with regulatory authorities may seem simple, but they constitute a highly complex, resource-intensive, and time-consuming task. It is always best to entrust these responsibilities to the experts.

Impact of Brexit on the Medical Device Industry

There have been significant effects of Brexit on the medical device industry. As the United Kingdom is officially leaving the EU, a lot of manufacturers are aiming to get UKCA accreditation in the forthcoming years.

New Regulations

New regulations MDR 2017/745 for medical devices and IVDR 2017/746 for in vitro diagnostic devices pose compliance challenges. Cert3Global provides legal assistance to companies for swift compliance, even with limited in-house resources.

Cert3global’s promise

We offer thorough regulatory consulting services for medical devices, aiding in registration, providing 510(k) guidance, and acting as a US agent for various device types. Our commitment to success ensures reliable outcomes, while our transparent pricing maintains consistency throughout our services, fostering trust and confidence in our clients.

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Clients Testimonials

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 between.

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 goals efficiently.

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 complicated regulatory assistance which they make simpler to go through.

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 manufacturer who wishes to smoothly enter in more markets.