We aim to help Med-Tech businesses to prepare for the EU Medical Device Regulation (EU MDR) in a productive and beneficial manner. 

The EU MDR must be fully implemented by May 26, 2020. We know that many businesses are uncertain of the consequences of the EU MDR and what actions to take. It is 13FOUR85’s mission to assist you in this process, secure innovation and support the continuous introduction of top class medical devices in the EU.

We support EU MDR compliance for Med-Tech businesses and aim to guide you through the process.

Post-Market Surveillance Tool

Get the latest Market Intelligence and stay on top of the situation with our tool to Post-Market Surveillance Systems tailored to operate in the Life Science Industry.

The tool guarantees 24-7 coverage of relevant academic and patent databases, plus media outlets and social media.

Conformity Assessment

To market a medical device a company must perform a EU MDR Conformity Assessment. 13FOUR85 can assist you in running this Conformity Assessment, and the output will be a gap identification overview.

In case of potential gaps, 13FOUR85 will provide a detailed project plan for mitigation.

Quality Management System Tool

Our ISO 9001:2015 certified Quality Management System tool assists you in establishing and maintaining a process-oriented life cycle approach to your Medical Device.

The tool supports your journey to EU MDR compliance and ensures Quality, Performance and Safety of your Medical Device.

Get YOUR FREE 30-DAY-TRIAL of our PMS or QMS tool

Order a free DEMO here

We want to facilitate the process of becoming EU MDR compliant. You will become a valued partner, and be guided through the following four steps by our 13FOUR85-team to ensure that you get the most out of your 30-day-trial of one or both of our SaaS-Solutions.

We aim to help Med-Tech businesses to prepare for the EU Medical Device Regulation (EU MDR) in a productive and beneficial manner. 

The EU MDR must be fully implemented by May 26, 2020. We know that many businesses are uncertain of the consequences of the EU MDR and what actions to take.

It is 13FOUR85’s mission to assist you in this process, secure innovation and support the continuous introduction of top class medical devices in the EU. 

We support EU MDR compliance for Med-Tech businesses and aim to guide you through the process.

Post-Market Surveillance Tool

Get the latest Market Intelligence and stay on top of the situation with our tool to Post-Market Surveillance Systems tailored to operate in the Life Science Industry.

The tool guarantees 24-7 coverage of relevant academic databases, media outlets and social media.

Conformity Assessment

To market a medical device a company must perform a EU MDR Conformity Assessment. 13FOUR85 can assist you in running this Conformity Assessment, and the output will be a gap identification overview.

In case of potential gaps, 13FOUR85 will provide a detailed project plan for mitigation.

Quality Management System Tool

Our ISO 9001:2015 certified Quality Management System tool assists you in establishing and maintaining a process-oriented life cycle approach to your Medical Device.

The tool supports your journey to EU MDR compliance and ensures Quality, Performance and Safety of your Medical Device.

Get YOUR FREE 30-DAY-TRIAL of our PMS or QMS tool

Order a free DEMO here

 We want to facilitate the process of becoming EU MDR compliant. You will become a valued partner, and be guided through the following four steps by our 13FOUR85-team to ensure that you get the most out of your 30-day-trial of one or both of our SaaS-Solutions.

Contact

Contact 13FOUR85 to start your tailor-made guided journey today.

+45 71 74 19 20

Contact

Contact 13FOUR85 to start your tailor-made guided journey today.

+45 71 74 19 20