Project Budget Planning
Purpose
This document is a forecast of the projects planned by the product development department, which is comprised of many teams. It is intended to be used for planning grants and funding applications.
Regulatory and Compliance
Overall Summary
Japan Market Entry & Conformity
[JAPAN_MARKET_ACCESS]HIGHAchieve market access in Japan by fulfilling all necessary regulatory requirements, including authorized representation, device conformity assessment, and facility registration.
Saudi Arabia Market Access
[SAUDI_MARKET_ACCESS]HIGHObtain product registration and authorization to market the medical device in Saudi Arabia via the Saudi Food and Drug Authority (SFDA).
Switzerland Market Access
[SWITZERLAND_AR]MEDIUMAppoint an Authorized Representative to maintain regulatory compliance for the medical device in the Swiss market.
Mexico Market Access (COFEPRIS)
[MEXICO_MARKET_ACCESS]MEDIUMSecure medical device registration and approval from the Federal Commission for the Protection against Sanitary Risk (COFEPRIS) in Mexico.
Brazil ANVISA Compliance (2026)
[BRAZIL_MARKET_ACCESS_2026]HIGHMaintain regulatory compliance for the medical device in Brazil, focusing on hosting and post-market surveillance annual fees for the 2026 fiscal year.
Internal Audit ISO 13485 (2026)
[ISO13485_INTERNAL_AUDIT_2026]HIGHConduct the annual internal audit required to maintain the ISO 13485 quality management system certification in 2026.
FDA 510(k) Annual Compliance (2026)
[FDA_COMPLIANCE_2026]HIGHEnsure ongoing regulatory compliance with the US FDA for the medical device post-510(k) clearance, including annual fees and a planned retrospective clinical study.
CE Marking & ISO 13485 Maintenance (2026)
[CE_MARKING_2026]HIGHMaintain CE mark certification under MDR/MDD and the ISO 13485 certificate through annual surveillance audits and fees in 2026.
AECOC (GS1) Renewal (2026)
[GS1_2026]LOWRenew the annual GS1/AECOC fee for the maintenance of product identification codes (barcodes).
ISO 27001 Certification (2026)
[ISO27001_CERT_2026]MEDIUMAchieve and maintain ISO 27001 Information Security Management System certification, including consulting and audit fees in 2026.
- All cost estimations are in EUR
- Hours are calculated based on 8-hour work days
- FTE (Full-Time Equivalent) calculated as hours ÷ 2080 annual hours
Medical Data Science
Overall Summary
Next-Generation AI Algorithm Development
[ML-ALG-001]HIGHDevelop improved deep learning models for skin lesion classification with enhanced accuracy
MLOps Infrastructure Upgrade
[ML-INFRA-001]MEDIUMModernize machine learning pipeline infrastructure for faster experimentation
Rare Disease Dataset Acquisition
[DATA-ACQ-001]MEDIUMAcquire specialized datasets for rare dermatological conditions
- All cost estimations are in EUR
- Hours are calculated based on 8-hour work days
- FTE (Full-Time Equivalent) calculated as hours ÷ 2080 annual hours
Other Software Development
Overall Summary
Mobile App Redesign and Feature Expansion
[MOBILE-001]HIGHComplete redesign of mobile applications with new patient-facing features
Public API Platform Development
[API-001]MEDIUMBuild comprehensive public API for third-party integrations and partnerships
EHR Integration Module
[EHR-INT-001]HIGHDevelop standardized integration modules for major EHR systems
- All cost estimations are in EUR
- Hours are calculated based on 8-hour work days
- FTE (Full-Time Equivalent) calculated as hours ÷ 2080 annual hours
Clinical Evidence
Overall Summary
Multi-center Clinical Validation Study
[CLIN-VAL-001]HIGHProspective clinical validation study across 5 European hospitals to demonstrate diagnostic accuracy and clinical utility
Scientific Publication Program
[CLIN-PUB-001]MEDIUMGenerate peer-reviewed publications to support clinical evidence and market access
- All cost estimations are in EUR
- Hours are calculated based on 8-hour work days
- FTE (Full-Time Equivalent) calculated as hours ÷ 2080 annual hours