Automated population & creation of the Summary of Safety and Clinical Performance

The Medical Device Regulation (MDR) has brought several obligations and requirements regarding reporting, safety, and other risk-preventive actions. These processes and the effort that comes with them, has left a lot of companies struggling with the regulatory workflows. The Intelligent Automation solution by lexoro helps our clients in the medical device sector to accelerate the preparation, the population and the generation of chapters and sections within the Summary of Safety and Clinical Performance (SSCP). This way, the workload for these summary reports – obligatory for Class III and implantable devices – can be reduced significantly. lexoro´s big performance-plus: a degree of automation of about 70%.

The challenge

Class III and implantable devices usually mean a higher level of risk for the patient. Therefore, the Medical Device Regulation has seen the necessity for a routine summary to display clinical data regarding the safety and performance of such devices. While the Post Market Surveillance process is going on regularly, the SSCP has to be updated once a year as well. The challenge for manufacturers lies in the additional effort that has to be put into this short summary – collecting clinical data, updating outdated information, choosing an appropriate language that is readable for the general public and making it accessible after several checks by Notified Bodies. And all this in accordance with the current requirements of the MDR.


The problem

  • High time expenditure for a routine-based workload
  • Manual collection, copying, distribution, and updating of information, text elements, tables from various systems
  • Time-consuming copy & paste tasks for several chapters and sections
  • Populating relevant information into templates for the SSCP


Being a globally active company within the medical device sector and a portfolio also includes the high-risk implants and Class III devices, our customer wanted to accelerate the tedious work for the preparation of SSCPs. This was only one step in the company´s journey to regulatory excellence under new MDR requirements where lexoro is a key partner.

The solution: Intelligent Automation for Summary of Safety and Clinical Performance (Class III & Implants)

For the intelligent solution to accelerate the SSCP workflow, lexoro has leveraged the power of RPA and NLP and consequently restructured the preparation and population. This way, lexoro can enable and inspire a company´s top regulatory experts by either completely removing or semi-automating routine tasks. Typically, these tasks would include the likes of copy & paste, data collection, and content population. With lexoro´s innovative Intelligent Automation technology, regulatory departments can save up to 70%. And by introducing the fully flexible and customized solution into your system environment, the transition runs almost seamlessly.

The process

The initial and only manual step includes the selection of a template for the summary or the report to be created. In the following, software robots automatically search through internal systems to collect relevant information and data. These can be textual, tabular, numeric or other data that fits the relevancy criteria for the respective template or chapter. After the collection of the data basis is completed successfully, it is possible to prepare, format and supplement the data using Natural Language Processing. In the final step, the lexoro solution processes the fully automatic population of the defined templates & tables with relevant data into the designated summary chapters and exports the finalized document in a format of choice.

1Choose template or chapter

Manual selection of the required template or chapter to be processed or generated.

2Creation of data basis (upload or collect)

Automated collecting and copying of relevant data and text from source data (e.g., the PMCF, IFU, CEP, CER, or technical documentation) to create a data basis.

3Formatting and Aggregation

Extraction, preparation, editing, and formatting of data, text, and tables for the SSCP.

4Transfer, Filling and Population

Filling and population of prior defined chapters and tables with relevant data and text (e.g., Summaries, Performance & Safety, etc.).

5Preview and Export

Transfer and Export in company-specific SSCP templates for further processing.

The benefits for the customer

100% error-free RPA technology combined with AI-supported processes leads to a standardized workflow
  •  Automated support for preparation & creation of SSCPs – approx. 70% time saving
  • 100% error-free RPA technology with support of AI – individual solution for your needs
  • Standardization of the workflow – MDR-compliant creation of chapters and subsections
  • Problem-free integration of the automation solution into your existing system landscape
  • Fast support and thus relief for your top experts – directly measurable ROI

The savings potential achieved

2.000 h / 150.000 €
Reduction in work performed per year. Total up to 2 FTE at 70% PQ

Have your savings potential calculated now!

Do you want to write your own success story with the help of Intelligent Automation? Contact our experts for RPA, NLP
and Machine Learning and learn how to accelerate Overviews and Summaries and how much you can save with the innovative automation of your workflows and processes.

Your contact person

Sebastian van der Meer

Managing Director

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