qtec TrendReport – a service for your organization
Trend reporting in accordance with Art. 88 of the MDR is growing in importance. The FDA, government authorities and notified bodies are increasingly focusing on the reporting of trends. As experts in the field, we have developed a service that handles the entire creation of audit-compliant trend reports for manufacturers of medical devices.
Full service for the reporting of trends in accordance with Art. 88 of the MDR
Trend reporting is an art. Surveys have shown that most companies create these reports using Excel spreadsheets and spend between 25 and 100 person-hours per month on this task, depending on the product portfolio. But there is another way: with our TrendReport service, we offer you a convenient and cost-effective option that also provides additional benefits.
Dr. Hans-Joachim Graf, Managing Director
- monthly full-service offering for medical devices
- Transfer of customer data
- audit-compliant format
- Contract term of 12 months
- dedicated contact person
- Support by a trained team of experts
- free trial report
How TrendReport works:
- for each analysis, we apply several suitable statistical methods to ensure trends are detected and both false-positive and false-negative trend notifications are effectively suppressed based on the data structures.
- We use validated software tools to facilitate the effective and efficient processing of large amounts of unsorted data.
- We can customize key evaluation metrics, such as evaluation periods, significance level and sample size, depending on the specific characteristics of our customers’ products.
- of course, we also take sales figures and the accumulated installed base into account when calculating trends.
- We are also able to find trends that are created through a combination of different characteristics (e.g. a specific product in a specific target market).
Improve quality through data analysis
TrendReport can do more than just provide you with compliant reports. The skillful combination of data sets has already allowed us to successfully identify problems and find sources of error in the manufacture of medical devices. As a result, TrendReport enables us to detect quality issues for our customers that would otherwise be impossible to identify.
Using a concrete example, data analysis allowed us to identify a production problem at a plant in Spain for an international medical device manufacturer – before the customer was able to do so themselves. The manufacturer was then able to target the issue effectively.
Still not convinced? Attend our free webinar
In our three-hour webinar, you will learn how to:
- meet the regulatory requirements imposed by the FDA and the MDR/IVDR
- reliably distinguish “real” trends from false-positive anomalies
- identify early trends and use them for continuous improvement or preventative measures
- present all relevant information in a meaningful way for evaluation
Try TrendReport free of charge
Test us. We offer complete trend reporting in compliance with Art. 88 of the MDR. We use your data records and provide you with a report shortly afterwards. Contact us now. Our experts will be happy to answer your questions, and you will receive your first TrendReport free of charge.