to automate your internal processes
Technical Documentationto launch your medical devices years earlier
Team
About the CertHub Team
Maintain all your structured product information in a single source of truth to minimize inconsistencies when referencing data and eliminate the need to copy and paste information. High transparency and advanced traceability enable colleagues from quality and regulatory affairs to find and edit data with high efficiency, and the streamlined workflow ensures that regulatory documentation per product is created much faster.
MedTechs can focus on what matters - getting products to market faster to generate revenue.
Maintain all your structured product information in one single source of truth.
High transparency of product- and company-related data
Minimized inconsistencies and increased efficiency
Maintain all your structured product information in a single source of truth to minimize inconsistencies when referencing data and eliminate the need to copy and paste information. High transparency and advanced traceability enable colleagues from quality and regulatory affairs to find and edit data with high efficiency, and the streamlined workflow ensures that regulatory documentation per product is created much faster.
MedTechs can focus on what matters - getting products to market faster to generate revenue.
Use the same content with @ ... in multiple parts, but maintain it only once, by referencing single source of truth of product data and QMS.
Entire verification records can be aggregated automatically and transformed to a list to safe hours of formatting in the quality and regulatory affairs department.
Of course, images, tables and all familiar formatting are supported.
Reference the single source of truth with @ ... to manage content only once, but use it in multiple documents.
Reference product data and QMS in endless sections to avoid copy & paste and solve cursory editing errors
Transform data (e.g., verification records) into tables and lists with zero effort
Use the same content with @ ... in multiple parts, but maintain it only once, by referencing single source of truth of product data and QMS.
Entire verification records can be aggregated automatically and transformed to a list to safe hours of formatting in the quality and regulatory affairs department.
Of course, images, tables and all familiar formatting are supported.
Use standardized templates based on Notified Body expectations or add your own for multiple individual products. By automatically populating the product data, certain sections can be created almost automatically. With the push of a button, the entire report can be exported as PDF file for complete documentation.
CertHub provides an executive summary of the current status and blockers of individual sections of the technical documentation.
Fill standardized templates for the technical documentation automatically with product data and export the final documents as PDF files.
Automatically fill and update technical documentation templates with product and company data
Executive summary of current status and blockers
Use standardized templates based on Notified Body expectations or add your own for multiple individual products. By automatically populating the product data, certain sections can be created almost automatically. With the push of a button, the entire report can be exported as PDF file for complete documentation.
CertHub provides an executive summary of the current status and blockers of individual sections of the technical documentation.
With customized templates that can be created for Medical Device Regulation (MDR), FDA 510(k), Anvisa or Pharmaceutical and Medical Device Act (PMD Act) and others, the same product data can be used for multiple jurisdictions, making regulatory maintenance and compliance very easy. With only little effort, new markets and revenue potential can be unlocked.
Manage content only once, and reuse the same product data in multiple technical documentations and admissions for additional jurisdictions.
Create additional TDs with low effort for existing products
Unlock new markets and revenue potential
With customized templates that can be created for Medical Device Regulation (MDR), FDA 510(k), Anvisa or Pharmaceutical and Medical Device Act (PMD Act) and others, the same product data can be used for multiple jurisdictions, making regulatory maintenance and compliance very easy. With only little effort, new markets and revenue potential can be unlocked.
Understand product and process development changes even years into the future. With CertHub, you can confidently prove your product updates and releases and jump to previous versions, including all relevant documentation.
Demonstrate continious compliance and track all product and company updates.
Continious version control
Understand product and process development changes even years into the future. With CertHub, you can confidently prove how your product has evolved during the development and maintenance cycle, jump to previous versions and demonstrate compliance in audits.
CertHub Smart Search is your smart colleague. Ask your questions to the chatbot in natural language and CertHub will find the information based on all company and product data to give you a quick overview or to take you directly to the right place to continue working on the details.
CertHub Smart Search is your smart colleague.
Chatbot in natural language based on all company and product data
CertHub Smart Search is your smart colleague. Ask your questions to the chatbot in natural language and CertHub will find the information based on all company and product data to give you a quick overview or to take you directly to the right place to continue working on the details.
