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Experts for Medical Devices
Based in Germany, MeinDoc is a full-stack consulting company for MedTech sector. We provide regulatory affairs consulting and market access services to help clients navigate compliance and achieve market success.
Software Development Lifecycle (SDLC) Compliance per IEC 62304
- End-to-end support for implementing and documenting IEC 62304-compliant SDLC processes, including software classification, architecture definition, verification & validation planning, and maintenance controls.
Comprehensive Software Risk Management and Cybersecurity Assessments
- Execution of software risk assessments in accordance with ISO 14971 and IEC 81001-5-1, including cybersecurity risk evaluation per AAMI TIR57 and FDA premarket cybersecurity guidance.
Success Stories
"Working with MeinDoc was instrumental in accelerating our device development and compliance requirements. Their deep understanding of regulatory landscapes and technical expertise were invaluable in navigating the complex regulatory processes and ultimately bringing our innovative device to market faster than anticipated ."
" MeinDoc helped us develop and execute a comprehensive market entry strategy for our medical device. Their knowledge of the market landscape and their ability to navigate the complexities of international regulations were invaluable."
Prämium Inserate
