We solve MDR for your medical devices

Streamline your Pre-CE and PMCF study with our MDR team of experts. We offer customizable services that will meet your needs to comply with EU MDR 2017/745.

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Clinical investigation

Pre-Registration Study


Demonstrate that your medical device is safe and effective for its intended use


Determine how medical device affects the trial subject


Clarify your medical device’s side effects and assess their risks


Define your study - design

ISO 13485 certification


PMCF step by step

The medical device industry is facing unprecedented regulatory, cost, and resource pressures with the implementation of EU MDR. Under the Medical Device Regulation (MDR) in the European Union, medical device manufacturers must comply with the PMCF process, also known as Post-Market Clinical Follow-up.



Determining the scope and objectives of the PMCF research and developing a strategy that specifies the study design, data collection strategy, and statistical analysis methods. See more



Documents preparation database launch (data management plan and data validation plan). Database creation, validation rules settings, testing, technical manual, creation of user accounts, preparation of data exports. See more

Data collection

Data collection

Secure data collection with electronic data capture (EDC) system CLADE-IS. Database is monitored and assessed for any discrepancies (queries) by a data manager and consulted with the physician in order to collect only the highest quality data. See more

Data Analysis

Data Analysis

Before data analysis we provide data review to find any potential errors. Analysis is done in renowned statistical software (import, data derivation, statistical analysis). We are able to provide various outputs (tables, graphs and lists). See more



Report includes description of statistical methods, data and results in the form of tables, figures and lists including their interpretation from the statistician's point of view. We are also able to provide raw data and outputs. See more

Is your project ready for PMCF?

1. Is your medical device CE marked?

2. What is the class of your medical device?

3. Have there been any significant changes to your medical device since its CE certification?

4. Is your medical device considered to pose a high risk based on its materials, indication, or target population?

5. Was your medical device based on equivalence?

6. Does your pre-clinical data have any gaps?

7. Is there any new information on the safety or performance of your medical device?

8. Are there any unanswered questions regarding the safety and performance of your medical device?

9. Have you identified any risks from data sources (literature, market, etc.) for similar medical devices?

10. Does your medical device interact with other medical products or treatments?

11. Does your medical device need continued validation due to a discrepancy between pre-market follow-up and expected product lifetime?

12. Can you generalize your clinical investigation results?

13. Has your medical device been verified on a varied population?

Clinical Investigation is needed first.

Contact us for more information.

You might need PMCF. Contact us for more information.

Contact us for more information.

You might not need PMCF. If you are still not sure about PMCF, contact us for more information.

Contact us for more information.

How do we work?

Clinical data expertise

End-to-end services

Advanced technology and analytics tools

Forget paper forms or overpriced electronic data capture systems (EDC). Our vision is Healthy Data that is why we have developed CLADE-IS and include it in our services.


We will help you navigate
the waters of regulatory affairs


On medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC

MDCG endorsed documents and other guidance
ISO 14971 Medical devices

Application of risk management to medical devices

ISO 14155 - Medical devices

Clinical investigation of medical devices for human subjects — Good clinical practice

ISO 13485 – Medical devices

Quality management systems — Requirements for regulatory purposes

EU Regulation 2016/679 – GDPR (General Data Protection Regulation)

On the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing

ISO 9001 - Quality management Systems


ISO 27001 – Information security

Information security management systems

About IBA

Institute of Biostatistics and Analyses is a contract research organization (CRO) with extensive experience in clinical data collection and analysis, completing 300+ projects in 25 countries. We partner with professional societies, pharma, medical device and IVD manufacturers, and grant teams. We have our own web-based systems for data collection, validation, and analysis.

Our services

Data Management

Explore page

Data Analysis

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EDC system

Explore page


Explore page

PMCF Checker

Our PMCF Checker is a quick test to see if your medical device needs a PMCF system for regulatory compliance.

Let’ start


CLADE-IS represents an information system for clinical data warehousing. Researchers in health and life sciences industry use this EDC platform (Electronic Data Capture) for secure and intuitive data management. CLADE-IS is in compliance with ISO 13 485.


Comparision of Electronic Data Collection
(EDC) System vs. Paper Data Collection

Robust eCRF +
Surveys +
Medical device registries +
Safety reporting +
Cloud-based EDC system +
Also available as a service (SaaS) +

Paper Forms
- Slower data collection and entry
- Delayed data availability and analysis
- Increased errors and data inaccuracies
- Poor data management and security
- Limited ability to monitor data quality
- Increased paper usage and waste

Give us your contact details and we’ll get in touch with you for your free consultation.

*Schedule a consultation with us to discuss your PMCF study in details.
The online call will take up to 30 minutes based on which we will be able to provide you with a PMCF solution that will fit your needs.

Or get in touch with Michal if you need anything else!

Michal Jetelina
Business Development Manager
+420 722 357 458
Poštovská 68/3, 602 00 Brno, Czech Republic
Michal Jetelina

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