Life cycle management.
Optimized.

Medical devices must be managed holistically using a proven and continuously improved approach. Our life cycle management has been developed, tested and verified with numerous stakeholders over 20 years and fully meets the new MDR requirements.

Full life cycle care by Device25

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Product development

Post-market surveillance

Product development

Post-market surveillance

Device25 the fly / life cycle management

Idea 
Great devices start with great ideas 

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Clinical claim and benefit definition 
The backbone of your medical device 

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Clinical evaluation plan (CEP) 
The roadmap of clinical evidence 

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Development and verification 
Technical and pre-clinical testing

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Clinical evidence generation 
Collect patient data of sufficient amount and quality to allow a qualified assessment 

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Claim validation 
Demonstrate clinical claims through pre-clinical and clinical evidence 

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Clinical evaluation report (CER) 
Compare your medical device performance with the current state of the art for conformity assessment 
 
Summary of safety and clinical performance (SSCP) 
Periodic information publicly available for users (EUDAMED) 

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Post-market surveillance (PMS) plan 
The roadmap to collect overall device-related information 
 
Post-market clinical follow up (PMCF) plan 
The roadmap to collect clinically relevant data 

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CE marked medical device 
A big achievement – congratulations! 

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Post-market clinical follow-up (PMCF) investigation 
Continuously collect patient data 

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Promotion 
Utilize your clinical claims properly 
 
Training 
Ensure safe use of your medical device 
 
Distribution and put into service 
You have brought your medical device on the market 

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Vigilance data 
Collect publicly available intended purpose-related data 

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Literature search 
Periodic check of the state of the art 
 
Competitor analysis 
Periodic comparison 

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Performance monitoring 
Analyze all relevant clinical data in relation to sales figures to reach a sound conclusion about the clinical performance of the medical device

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Clinical evaluation report (CER) 
Periodic update 
 
Summary of safety and clinical performance (SSCP) 
Periodic update 
 
Periodic safety update report (PSUR) 
Benefit-risk evaluation report considering sales and vigilance data as well as corrective actions 
 
PMS report 
Overall device-related information 
 
PMCF evaluation report 
Clinically relevant data 

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Product phase out 
Collect data until end of life cycle

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Click on pictograms to learn where specific know-how is needed.
Device25 icon claim management
Device25 icon clinical evidence generation
Device25 icon surgeon network

Case

The NematX case
Technology development for medical applications

NematX is a Swiss startup company from the Swiss Federal Institute of Technology (ETH Zurich), specialized in additive manufacturing

Situation

NematX approached us as they wished to enter the medical device market with their technology. They were lacking the know-how and insight in this area. 

Approach

Solution

Development of a concept paper that allows for strategic decision making to enter the medical device market with subsequent kick-off of the collaboration project to develop a medical device 

Dr. Raphael Heeb
Dr. Raphael HeebCEO of NematX
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Having a revolutionary additive manufacturing technology developed, we identified the medical devidce field as an attractive target market. Device25 has greatly familiarized us with the medtech industry and suggested thereapeutic areas to focus on according to our USPs. We are now in the process of developing unique 3D printed medical devices in close collaboration with Device25.

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