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!


CONTACT US

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!


CONTACT US

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!


CONTACT US

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!


CONTACT US

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!


CONTACT US

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! 


CONTACT US

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!


CONTACT US

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!


CONTACT US

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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... 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

Contact

Drop us a line for free consultation!

CONTACT US

Our office

Wangenstrasse 72

8600 Dübendorf

Switzerland


+ 41 43 543 14 25