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.
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.
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
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.
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
Application of risk management to medical devices
Clinical investigation of medical devices for human subjects — Good clinical practice
Quality management systems — Requirements for regulatory purposes
On the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing
Requirements
Information security management systems
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 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
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
