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EU-MDR
compliance 
Assessment

Supporting your Medical Device Regulation Transition

Complete the compliance assessment to receive a customised solution for your MDR needs
 
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What is the EU-MDR and How Will It Impact us? 

In May 2017, the European Commission voted to approve new Medical Device Regulations. This will result in widespread changes in how devices are manufactured, the level of compliance and clinical data required to bring them to the European market.

This is the most significant update of the regulations that govern medical devices in Europe in recent history. 

The MDR defines the term “medical device” as any “instrument, apparatus, appliance, software, implant, reagent, material or other article"

The Regulation will affect all medical device manufacturers, importers, Subcontractors/suppliers distributors and EU Representatives. 

Transitioning to the MDR is overwhelming and many companies don't know where to start. But with our assistance, experience and network the MDR does not need to be a challenge for your organisation. 

Start you assessment today!

Panda's MDR Compliance Assessment

Our Compliance Assessment Is Based on a 3-Step Procedure That Guides Your Company towards being MDR compliant

Gap Assessment & MDR Compliance Analysis

This will generate a task list and road-map for updating your procedures and documentation. It will also outline what areas of your business will need to be changed in order to be MDR compliant. We can connect you with QA/RA expert consultants who will evaluate your Quality Management Systems, technical and clinical data documentation. 

MDR Training

Expert consultants will facilitate a personalised training program for the areas of your business the MDR will have an impact. The purpose of this training is to update your employee's industry knowledge and expertise. 

MDR implementation 

After the MDR training is complete, your organisation will now have the necessary knowledge, tools and expertise to implement the new regulations on your medical device products.
You are now on the way to becoming MDR Compliant
After finishing our compliance assessment and training, 
Your company will have strategies in place to effectively deal with the MDR. 

Have questions on The MDR? Request More information from our experts

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