🔹 𝗘𝘅𝗽𝗲𝗿𝘁𝘀 𝗶𝗻 𝗠𝗲𝗱𝗶𝗰𝗮𝗹 𝗗𝗲𝘃𝗶𝗰𝗲 𝗖𝗼𝗺𝗽𝗹𝗶𝗮𝗻𝗰𝗲, 𝗤𝗠𝗦 𝗗𝗶𝗴𝗶𝘁𝗮𝗹𝗶𝘇𝗮𝘁𝗶𝗼𝗻 & 𝗣𝗿𝗼𝗷𝗲𝗰𝘁 𝗠𝗮𝗻𝗮𝗴𝗲𝗺𝗲𝗻𝘁 🔹

We help MedTech companies navigate regulatory complexity and accelerate compliance through tailored services in three core areas:

🔧 Regulatory Affairs & Compliance

• EU MDR 2017/745, FDA 21 CFR Part 820 & MDSAP consulting
• ISO 13485 QMS implementation & certification
• Technical documentation & CERs for MDR/FDA
• EU & US device registration support
• Audit readiness (Notified Bodies, FDA, MDSAP)
• Internal audits & gap assessments (MDR, ISO 13485, 14971, 62304)
• Risk management (ISO 14971), design control (IEC 62304), cybersecurity (IEC 81001-5-1, FDA)
• ISMS implementation (ISO 27001, 27701)

💻 Digital QMS Solutions

• QMS digitalization with Jira, Confluence, SharePoint & Power Automate
• Software validation for regulated environments
• AI in RA/QA per ISO 42001
• Workflow automation (training, CAPA, document control)
• Custom tools for regulatory document management

📈 Medical Device Project Management

• End-to-end project management for medical software development
• Cross-functional coordination (RA, QA, R&D, clinical, risk)
• MDR/FDA submission management
• QMS & certification oversight (ISO 13485, MDSAP, ISO 27001, ISO 42001)
• Resource planning, risk mitigation & stakeholder alignment
• Project tracking via Jira, Confluence, or SharePoint

Let’s make compliance a catalyst for innovation, not a bottleneck.

QMLogic

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QMLogic

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