Essential life cycle care for your medical device in the age of MDR
Our services
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Full life cycle care
We are the experts for life cycle care of your medical device.
Our specialty is to generate sound clinical evidence to bring and keep your medical device on the market.
Work with us and you will receive a holistic approach combined with a fully digitalized business process to meet all requirements of the MDR!
Hands-on expertise
We have more than 50 years of combined expertise in the medical device field. Some of our achievements include:
- Strategic planning and execution of close to 1'000 clinical investigations in EU, North and South America, Asia and the Middle East
- Development of several medical devices in classes I – III including active medical devices, dental and orthopedic implants and instruments
- Generation of clinical evidence to ensure success of several EU Notified Body, FDA 510(k) and JPMDA submissions
We are experts and are very happy to share our knowledge with you and your organization!
One-stop CRO
We are the one-stop CRO that creates tailormade solutions to meet your exact needs.
Are you struggling to come up with a sound strategy to support your product claims and collect clinical evidence?
We offer every service from idea to publication. Do not hesitate to contact us - no matter how small your inquiry is!
Global surgeon network
We have access to over 20'000 surgeons in more than 1'000 clinics worldwide in
- orthopedics
- trauma
- craniomaxillofacial
- and neurosurgery
Or are you in need of a distinguished key opinion leader? We are very happy to make an introduction and find your perfect match!
Full life cycle care
We are the experts for life cycle care of your medical device.
Our specialty is to generate sound clinical evidence to bring and keep your medical device on the market.
Work with us and you will receive a holistic approach combined with a fully digitalized business process to meet all requirements of the MDR!
One-stop CRO
We are the one-stop CRO that creates tailormade solutions to meet your exact needs.
Are you struggling to come up with a sound strategy to support your product claims and collect clinical evidence?
We offer every service from idea to publication. Do not hesitate to contact us - no matter how small your inquiry is!
Hands-on expertise
We have more than 50 years of combined expertise in the medical device field. Some of our achievements include:
- Strategic planning and execution of close to 1'000 clinical investigations in EU, North and South America, Asia and the Middle East.
- Development of several medical devices in classes I – III including active medical devices, dental and orthopedic implants and instruments
- Generation of clinical evidence to ensure success of several EU Notified Body, FDA 510(k) and JPMDA submissions
We are experts and are very happy to share our knowledge with you and your organization!
Global surgeon network
We have access to over 20'000 surgeons in more than 1'000 clinics worldwide in:
- orthopedic
- trauma
- craniomaxillofacial
- and neurosurgery
Or are you in need of a distinguished key opinion leader? We are very happy to make an introduction and find your perfect match!
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
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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
Contact
Drop us a line for free consultation!
CONTACT US
Our office
Wangenstrasse 72
8600 Dübendorf
Switzerland
+ 41 43 543 14 25
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