MedTech

Intelligent Automation for Medical Device Registration Workflows

Regulatory or Clinical Affairs. Quality Management and Assurance. Product Safety, Risk Management and Post Market Surveillance. All these departments and competences have to work hand in hand when it comes to the registration process for medical devices and products. Within the medical device industry and other regulated industries it is incredibly important to document, report, and monitor everything that is going on and happening during a product life cycle. Intelligent Automation supports this entire life cycle in documentation and reporting with powerful components and technologies. Often achieving an automation level of 70%.

lexoro has been developing and delivering successful solutions for well-known medical device companies for over 20 years, accelerating their registration and regulatory workflows in various fields. Read more about our solutions here.

The challenge

With massive amounts of data that need to be collected, screened, analyzed, and subsequently processed and reported, manual tasks that require human time and attention are an enormous challenge for departments dealing with registration matters. Standard tasks like document generation, data collection, text and table transfer, or formatting pose a big problem – including the human error factor and the spending of valuable time and resources in already tight timeframes. Due to constantly higher hurdles for registration, approval, surveillance, and assessment due to the MDR and FDA in diverse countries, these highly standard-based tasks hinder the whole workflow.

The problem

  • Highly qualified employees spending valuable time processing large amounts of data
  • Tedious data and text processing in various documents and reports
  • Recurring updating and transfer tasks for several product groups and drugs
  • Copy & Paste tasks, Data collection in diverse systems and databases, formatting and editing
  • Everything with viable, relevant, and compliant data

Customer

Our customers are broadly positioned, often with the same challenges of quality, flexibility, speed, and compliance. Reaching from globally active medical device and pharmaceutical enterprises, to medium-sized companies, to medical device service providers. All these customers trust in intelligent solutions powered by lexoro Automation with innovative approaches to accelerate and support tedious manual processes while delivering great results.

The solutions:
Intelligent Automation for Medical Device Registration Workflows

lexoro’s approach to automating these processes is based on Robotic Process Automation (RPA). Here, manual & tedious activities are learned and automated by so-called software robots. . Especially the „collection“ of information from different databases & operating systems and the populating & creation of documents and reports. The starting point is the manual selection of the necessary template and its parameters. Here, relevant information and key data are determined, such as the document type to be created and its areas, chapters & sections. Once these basic requirements have been determined, automation can begin.

Our Big Plus: Individual and customer-specific solutions for your special requirements and needs. Whether special formats, templates, systems, or databases, the customized solutions can accommodate just about anything.

The process

An overwhelming part within medical device deparrtments is spent on documentation and reporting with regulations and requirements becoming more complex including more and more data each year, making things even more complicated. With our Intelligent Automation solutions we focus on fast, precise, and efficient support for your processes. Our most successful and powerful solutions include Clinical Evaluation Plans, Clinical Evaluation Reports, and SSCP, PMS- or PMCF-Plan with diverse modules and chapters.

The used core components are adaptable for other types of documents and dossiers in the registration lifecycle – including data processing, formatting, transfer, population, export, etc. lexoro’s Intelligent Automation takes advantage of these challenges, releasing resources for your top experts.

Intelligent Automation for Registration Workflows & Documents in the Medical Device Industry1234lexoro AutomationTechnical DocumentationClinical Evaluation Plan (CEP)Clinical Evaluation Report(CER)SSCP andPMS- or PMCF-Plan

1Technical Documentation

  • Technical Documentation and in-house systems serve as starting point and data basis for the creation and generation of further documents and reports.

2Clinical Evaluation Plan (CEP)

  • Automated data transfer and population of Clinical Study Plans. Text and data is collected from the technical documentation or in-house systems to create and fill the CEP.

3Clinical Evaluation Report (CER)

  • As with the Clinical Study Plan, data, text, and tables can be transferred automatically from the CEP to the Clinical Evaluation Report (CER). Including relevant chapters and text segments with formatting and aggregation.

4SSCP and PMS- or PMCF-Plan

  • Intelligent Automation for registration documents like SSCP, PMS- or PMCF-Plan. The same core components as used above can be adapted here to automatically extract, prepare, edit, and format data, text, and tables for the various templates and chapters.

The benefits for the customer

Automated document generation with compliant processing & populating of data, text, and tables
  • Reduction of processing time: only approx. 25-30% have to be created and processed manually
  • 100% error-free RPA technology with the support of AI – individually tailored to you
  • Development of individual modules – you can design and determine special requirements
  • Standardization of the workflow – MDR- and FDA-compliant creation of regulation documents
  • Web-based Report & Document Generation. Secure data processing. Ready to use in 4-6 weeks

The savings potential achieved

ca. 3.300 h / 300.000 €
Reduction in work performed per year. Total up to ca. 3 FTEs 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, NLG
and Machine Learning and learn how much you can save with the innovative automation of your workflows and processes.

Your contact person

Michael Fischbäck

Business Development Consultant

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