We solve MDR for your medical devices
Streamline your PMCF study with our MDR team of experts. We offer customizable services that will meet your needs to comply with EU MDR 2017/745.
Streamline your PMCF study with our MDR team of experts. We offer customizable services that will meet your needs to comply with EU MDR 2017/745.
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
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
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
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.
The deadline for transitioning your medical devices to MDR is just around the corner. Stay ahead and get your new certificate under MDR in order to keep your medical device on the EU market
2017
EU MDR 2017/745 enters into force.
2022
EUAMED is launched. Periodic safety updates reports are required for all class IIb and III medical devices.
2024
From 26 May 2024 all devices placed on the market must be in conformity with the MDR
2020
Before the MDR is completely in effect, certificates issued under the MDD may still be valid for up to four more years.
2023
Periodic safety updates reports are required for class IIa medical devices.
2025
MDD devices already placed on the market before may continue to be made available till 27 May 2025
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.
Aneta Chytilová
Quality Assurance Manager
Marika Chrápavá
Head of Clinical Project Department
Lenka Mokrá
Deputy Head of Clinical Project Department
Michal Jetelina
Business Development
Manager
Matej Ivan
Business Development
Manager
David Pavlík
Head of Clinical Data Management Department
Michal Svoboda
Head of Data Analysis Department
Roman Vyškovský
Artificial Intelligence
Expert
David Kudláček
Head of IT Development Team
Our PMCF Checker is a quick test to see if your medical device needs a PMCF system for regulatory compliance.
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.
CLADE-IS
Faster data collection and entry +
Real-time data availability and analysis +
Reduced errors and improved data accuracy +
Improved data management and security +
Better ability to monitor data quality +
Reduced paper usage and waste +
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
