Draft a Consultation Report for regulatory taxonomy specialists recommending BRCS classification pathways and submission strategy for an AI-driven clinical decision support SaaS entering the EU MDR market

Generate draft a consultation report for regulatory taxonomy specialists recommending brcs classification pathways and submission strategy for an ai-driven clinical decision support saas entering the eu mdr market for Other Professional, Scientific, and Technical Services industry

Other Professional, Scientific, and Technical Services

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Upload complete technical file including IFU, risk analysis, clinical evaluation, intended use statement, software architecture, and AI model specifications per MEDDEV 2.1/6 and MDR Annex II/III
Current EU MDR classification status requiring BRCS pathway analysis
Primary clinical scenario where AI decision support will be deployed
Target market entry timeline affecting submission strategy urgency
Current status with potential notified bodies for BRCS consultation
Specify critical clinical evidence elements needed for compliance demonstration
Primary audience and format for the consultation report
Define specific Article 51 criteria requiring expert interpretation
Preferred pathway for managing EU market entry through BRCS
List current QMS standards and compliance gaps prompting BRCS need
Identify external regulatory factors affecting BRCS strategy