Your medtech experts.
From claim to market.
Ready for May 2021
The new Medical Device Regulation (MDR) enters fully into force on May 2021. It offers agile medtech companies many opportunities to stand out from the competition. Because MDR demands rigorous clinical evidence for class III and all implantable devices.
With a professional performance monitoring and ongoing public reporting about effectiveness and safety you don't just make sure your products stay on the market but also open up new market potential.
Our offerings
Answers to the
Medical Device Regulation
Know how during the entire product
life cycle
Hands-on expertise
Access to the world’s largest surgeon network
Answers to the
Medical Device Regulation
Know how during the entire product
life cycle
Hands-on expertise
Access to the world’s largest surgeon network
Idea
Great devices start with great ideas
Clinical claim and benefit definition
The backbone of your medical device
Clinical evaluation plan (CEP)
The roadmap of clinical evidence
Development and verification
Technical and pre-clinical testing
Clinical evidence generation
Collect patient data of sufficient amount and quality to allow a qualified assessment
Claim validation
Demonstrate clinical claims through pre-clinical and clinical evidence
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)
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
CE marked medical device
A big achievement – congratulations!
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
Post-market clinical follow up (PMCF) investigation
Continuously collect patient data
Vigilance data
Collect publicly available intended purpose-related data
Literature search
Periodic check of the state-of-the-art
Competitor analysis
Periodic comparison
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
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
Product phase out
Collect data until end of life cycle
Full life cycle care by DEVICE25
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Product development
Post-market surveillance
Hover pictograms below to learn where…
... is needed
Full life cycle care by DEVICE25
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Product development
Post-market surveillance
Idea
Great devices start with great ideas
Clinical claim and benefit definition
The backbone of your medical device
Clinical evaluation plan (CEP)
The roadmap of clinical evidence
Development and verification
Technical and pre-clinical testing
Clinical evidence generation
Collect patient data of sufficient amount and quality to allow a qualified assessment
Claim validation
Demonstrate clinical claims through pre-clinical and clinical evidence
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)
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
CE marked medical device
A big achievement – congratulations!
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
Post-market clinical follow up (PMCF) investigation
Continuously collect patient data
Vigilance data
Collect publicly available intended purpose-related data
Literature search
Periodic check of the state-of-the-art
Competitor analysis
Periodic comparison
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
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
Product phase out
Collect data until end of life cycle
Your Medical Devices Assessment Day
We make sure that your medical devices comply with the Medical Device Regulation. In just one day.
CHF 3’500.-*
Why
- Unsure about MDR compliance
- Want a second opinion
- Missing expertise in clinical evidence generation, product development/registration or post-market surveillance
- Looking for market expansion or optimal product positioning
- Upgrade to state-of-the-art processes in clinical data generation
How
- Unique and proven one-day assessment with our experts
- Detailed analysis of your technical file
- Revision of your quality management system
- Expertise in claim and life cycle management
- At your premises or remotely
Benefit
- Expert advice throughout the whole life cycle
- Identification of critical points
- Security for strategic decisions
- Expertise in the new Medical Device Regulation
- Written and tailormade report in just one day
*The Assessment Day includes the preparation, implementation of the workshop and a written report. The price is valid for one medical device or up to three processes.
Contact
To your tailormade Assessment Day
CONTACT US
Our office
Wangenstrasse 72
8600 Dübendorf
Switzerland
+ 41 43 543 14 25