Certification Assistant

CertHub's Certification Assistant is a digital platform designed to guide MedTech and IVD startups and scale-ups through the CE certification process, from initial setup to submission. The platform combines an electronic Technical Documentation (eTD) system and an electronic Quality Management System (eQMS) in a single tool, built around MDR and IVDR requirements. It is intended to reduce the time, cost, and regulatory knowledge burden typically associated with bringing medical devices to market.

The platform has supported over 150 companies through certification and claims to reduce initial certification timelines to weeks rather than the typical six months, while also reducing costs associated with initial certification and lowering the regulatory strategy knowledge required from the user.

Core Workflow: Product Setup and Configuration

• Users provide details about their device, including classification, intended use, software components, risk levels, and target users.
• The platform configures a Knowledge Model based on the device information provided.
• Correct templates are preloaded and a complete submission structure is set up automatically.
• Documentation requirements are adjusted automatically based on the specific medical device properties and regulatory pathway.

Interactive Content Generation

• A regulatory AI guides users through follow-up questions step by step.
• Users fill in content required for Technical Documentation and QMS through a chat-based interface.
• Content areas covered include risk assessments, intended purpose statements, and usability summaries.

Submission Package Creation

• The platform automatically assembles a complete Technical Documentation package.
• Output files are formatted, traceable, and aligned with MDR/IVDR requirements.
• Submission-ready files are available for immediate download.

Device Type Coverage: Three Content Domains

• MediPureTech (Traditional Medical Devices, MDR): Covers Class I–III medical devices with QMS and technical documentation including design controls, risk management, clinical evaluation, and regulatory submissions. Relevant standards and frameworks include ISO 13485, EU MDR Technical Documentation, ISO 14971 (risk management), and IEC 62366 (usability engineering). Reported outcomes include 60% faster regulatory submissions and 40% reduction in regulatory review cycles.
• DxTech (In-Vitro Diagnostics, IVDR): Provides specialised content for IVD manufacturers, covering analytical and clinical performance studies, quality control, and IVDR-specific requirements. Includes IVDR compliance templates, performance evaluation frameworks, quality control procedures, and notified body submission support. Reported outcomes include a 50% reduction in IVDR transition costs and faster time-to-market for new diagnostics.
• SoftiTech (Software as a Medical Device, SaMD): Offers a framework for SaMD development covering software lifecycle processes, cybersecurity, AI/ML validation, and digital health regulations. Relevant standards include IEC 62304 (software lifecycle), AI Act compliance, ISO 14155 (cybersecurity), and digital health pathways. Reported outcomes include 70% faster SaMD development cycles and readiness for AI Act requirements.

Additional Platform Capabilities

• Conformity Checker and Gap Analysis
• QM Audit Checker
• UDI management and EUDAMED integration
• Technical Documentation management
• Quality Management System (QMS) tools

CertHub is positioned as a fully digital solution tailored specifically to the MedTech industry, adapting its documentation and regulatory guidance to the properties of each individual device rather than applying a generic template approach. The platform covers MDR, IVDR, and SaMD regulatory pathways within a unified tool.