Leveraging Automation & AI for Regulatory Compliance validation & verification, delivering 40% faster approvals and 30% reduction in errors for medical devices development.
Overview
FDA & EU & MDSAP has released hundreds new combined regulations with about 55% of them in just last 2 years. Regulatory team spends average 15+ hours/week to keep with it due to a lack of one stop shop of Smart Regulatory Central Platform.
- Ideation Phase: Automated regulatory assessment to identify right compliance requirements (MDSAP, FDA, EU MDR)
- Market Research: AI (LLM) based central regulatory platform for analysis of compliance in target market for said product from Device connectivity , Feature & Data reliability.
- Concept Development:Automated regulatory matrix for requirement trackability with FDA/ MDR guidelines.
- Design & Prototype:Automated design & review platform accordance with DQ (ISO, CFR, IEC).
- Regulatory Approval:Automation suite to Prepare and submit regulatory submission for 510(K) / CE Mark and Automated QMS to validate the Trial process. Then we have Clinical trial, Product launch and Post Market Surveillance.
HARMAN QARA solutions are built on AWS cloud and leverage AWS native services like HealthLake, Bedrock and Athena etc.
HARMAN's Offerings: Regulatory Advisory & Transformation Services Design Consulting & Assurance Usability Engineering Risk and process Assurance and Compliance Quality Management system Global Product Launch Support Post Market Assurance Cognitive QARA
Highlights
- AI Based Regulatory Landscape Analysis Platform Use Case – LLM powered global regulatory scanning tool to identify and access relevant compliance and create trackability with the design master (FDA/ EU MDR, MDSAP etc..). Benefits – 45% Reduction in effort spend in RA analysis and create RA roadmap (Saving ~25 Hours per week / person)
- Automated Submission Document Generation Use Case –Using LLM & AI powered system to compile required documentation FDA/CE Mark/EU MDR/MDSAP from all necessary forms and data to produce a submission document (e.g., DQ, IO, OQ, PO, MQ documents for FDA) Benefits – 55% Reduction in submission document preparation. 60% reduction in documentation errors.
- Adverse Event Reporting Monitoring Platform Use Case –Leverage sensor-to-insight solutions with right analytics data, trigger automated advance event report to 3rd party tools or regulatory authorities (MAUDE, EudraVigilace-EU, MedWatch, VigiBase, VRS & other private tools) Benefits – Compliance Assurance – Reduce reporting delays by 80%. Rapid Response – Reduce response time by 68%.
Details
Delivery method
Deployed on AWS
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Business hour support available for platform and service related queries. Please mail at marketplaceSupp@harman.com to get more information about the service offerings.