MeinDoc
MeinDoc is a full-stack consulting company based in Germany, specializing in the MedTech sector. They provide regulatory affairs consulting and market access services to help clients navigate compliance and achieve market success. Their expertise spans Quality, Regulatory, Scientific & Digital health, including support for medical devices, SaMD, digital health, AI, and EU Authorized Representative services.
Industries
Nr. of Employees
small (1-50)
Services
Regulatory strategy development, dossier preparation, interactions with regulatory authorities and notified bodies, and market access support for EU, US and other territories.
Design and implementation of QMS frameworks, certification coaching and audit support to meet ISO 13485 and related quality standards.
SDLC compliance per IEC 62304, software risk management, cybersecurity assessments, and adaptation of QMS to agile/DevOps practices.
AI/ML lifecycle governance, AI-specific risk management, bias mitigation and documentation aligned with FDA GMLP and EU AI Act requirements.
EU-based authorized representative services for non-EU manufacturers to fulfil obligations under EU MDR/IVDR and the EU AI Act.
Tailored training and eLearning on quality, regulatory and clinical topics including GMP, GLP, GCP, GDP and regulatory affairs.
Regulatory strategy development, dossier preparation, interactions with regulatory authorities and notified bodies, and market access support for EU, US and other territories.
Design and implementation of QMS frameworks, certification coaching and audit support to meet ISO 13485 and related quality standards.
SDLC compliance per IEC 62304, software risk management, cybersecurity assessments, and adaptation of QMS to agile/DevOps practices.
AI/ML lifecycle governance, AI-specific risk management, bias mitigation and documentation aligned with FDA GMLP and EU AI Act requirements.
EU-based authorized representative services for non-EU manufacturers to fulfil obligations under EU MDR/IVDR and the EU AI Act.
Tailored training and eLearning on quality, regulatory and clinical topics including GMP, GLP, GCP, GDP and regulatory affairs.
Expertise Areas
- Quality management and ISO 13485 compliance
- Regulatory strategy and dossier preparation
- Clinical evaluation and post-market clinical follow-up
- Software as a Medical Device (SaMD) compliance
Key Technologies
- ISO 13485 QMS
- ISO 14971 risk management
- IEC 62304 software lifecycle
- IEC 62366 usability engineering