What is Easy Medical Device offering

All you need to have a better understanding of Medical Devices

Quality management

We can help you build your complete Quality Management System for Medical Devices and even include our eQMS SmartEye

Regulatory affairs

We will help you register your products all over the world with the support of our team and network. We cover also MDSAP, EU MDR, IVDR, FDA, Middle East...

Compliance management

We can audit your company to comply with the internal audit requirement or audit your suppliers that you need to integrate on your Approved Supplier List. We can also execute Mock Inspection to test your company and be prepared for the real audit.

Innovation

You are in the process to design and develop a Medical Device? Then hire us to help you follow the requirements of the regulation from the beginning and not to have to redo that when the product will be already finished as this can cost you more money

Authorized Representatives

We have offices in EU, Switzerland and UK where we can become your Authorized Representatives. This is mandatory if your company is not located in these regions.

Importer

We are also offering the service of Importer for EU and Switzerland where we will execute all the inspections needed per the regulation and record all those elements on our files. An attestation of release will be provided to you as a proof that your product passed all the checks.

Contact Easy Medical Device if you need support for any Quality and Regulatory Affairs activities for your company

What customers say

Thanks for their support
Zoltan Dr. Balogh

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

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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Everything you want to know about medical devices

تنظيم الطباعة ثلاثية الأبعاد في صناعة الأجهزة الطبية (MDR 2017/745)

فلنتحدث عن الطباعة ثلاثية الأبعاد أو ربما تستخدم المفردات العلمية “التصنيع الإضافي“. أفضّل الطباعة ثلاثية الأبعاد لأنها أسهل في الفهم للجميع. (بالنسبة لأولئك الذين يسألون لا يوجد فرق بين التصنيع الإضافي والطباعة ثلاثية الأبعاد) مستقبل اقرأ المزيد…

Keep in touch

Contact details

Monir El Azzouzi

QA RA Medical Device Consultant
info@easymedicaldevice.com

UK Representative from January 1st, 2021

Contact us