mgregulatory.com

Your Medical Device Regulatory Partner

Getting and keeping your devices in the UK, EU and US markets

 

 
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What MG Regulatory is offering

Authorised Representative

We can provide Authorised Representative services as we have offices in Europe. This is mandatory if you’re not in Europe and want to take your products there

Regulatory affairs

We are experts in the EU MDR, EU IVDR, UK MDR, US FDA Compliance & 510(k)/De Novo/PMA. We can ensure your documentation is compliant to these to bring or keep your products in the market

UK Responsible Person

We have expertise navigating the UK regulation. One of the requirements is to have a UKRP if you are not UK based. We can act as your UKRP

Consulting

We can provide consulting for the full lifecycle of a medical device. From helping you to create an intended purpose to Post-Market Surveillance, we can do it all!

Market access

Many countries have specific in-country requirements. We can help you register your products all over the world!

Training

We provide full comprehensive training on all regulatory matters in relation to the EU, UK and US. This is tailored according to your specific requirements through crafted modules and can be delivered in person and virtually. Get in touch for more details.

Contact MG Regulatory if you need support for any Regulatory Affairs activities for your company

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What customers say

Thanks for their support

Zoltan Dr. Balogh

EU MDR remediation project Q1-Q3 2023
I am delighted with Easy Medical Device’s expertise in preparing a flawless Technical File for MDR compliance. Their professionalism, and clear communication helped us to navigate the complex realm of medical device regulations. The project was completed within the stipulated timeframe, showcasing their commitment to delivering results promptly without compromising on quality. I wholeheartedly endorse Easy Medical Device for its exceptional services.

Karen Jaffe

VP Regulatory Affairs
Monir and Fatemeh were a pleasure to work with on this project. The expertise and professionalism was abundant and allowed for excellent collaboration and ultimate success of the Technical File assessment by our Notified Body. Responses were timely and organized. Monir has an unparalleled command of MDR. Fatemeh is a conscientious, incredible work ethic and maintains good writing skills and thorough implementation of the technical file per regulation.

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