Aligning Regulatory Compliance with Legal and Data Protection Expertise
MedQAIR is proud to partner with ReadyTech Consulting, a European business advisory firm based in Romania, with strong capabilities in regulatory compliance, data protection, and advisory support for policy and documentation aligned with EU standards, particularly across Central and Eastern Europe.
ReadyTech supports startups and SMEs in understanding and meeting relevant regulatory obligations, improving internal business operations, and adopting best practices that reduce risk and support sustainable growth.
Together, we offer complementary capabilities: MedQAIR focuses on medical device and digital health regulatory compliance under frameworks like EU MDR, IVDR, and the upcoming AI Act. ReadyTech provides broader support to clients across industries who require policy development, internal process governance, and documentation alignment with EU regulations such as GDPR and ISO-based quality standards.
How This Partnership Helps Our Clients
Process-Focused Regulatory Support
While MedQAIR guides companies through product-level compliance (e.g. technical documentation, EUDAMED, PRRC duties), ReadyTech helps teams improve the internal processes that support ongoing compliance such as SOP development, internal documentation workflows, and quality management mapping.
Operational Optimization for Regulated Markets
From early-stage startups to growing SMEs, clients benefit from ReadyTech’s ability to map, assess, and optimize internal processes. This supports long-term readiness for audits, scale-up, and market expansion.
Data Protection and Privacy Governance
ReadyTech’s outsourced DPO services and privacy compliance support (aligned with EU Regulation 2016/679) help clients understand and manage GDPR obligations across their organization, an essential layer for companies handling personal or health-related data.
Support Across the Full Business Lifecycle
Together, we help MedTech and digital health clients align product compliance (EU MDR, IVDR, AI regulations) with broader operational and governance readiness, bridging a common gap between regulatory strategy and real-world execution.
A Proven Collaboration
This partnership is built on a shared success story. At Genomate Health, MedQAIR and ReadyTech Consulting worked side by side to help the company achieve ISO 27001 and ISO 13485 certification. While MedQAIR led the implementation of regulatory frameworks and quality systems, ReadyTech ensured compliance with EU data protection and privacy requirements, providing oversight and support throughout internal process reviews and documentation alignment.
That experience shaped a practical, trust-based collaboration, which is now extended to support other digital health and MedTech innovators across Europe.
Partner with us. Build with confidence. Launch with certainty.
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