​From MedTech Innovation to Compliant Market Access.
The Hub Team.
Your one-stop solution for ISO 13485, ISO 14971, and EU MDR/IVDR compliance, regulatory dossier reviews, and quality documentation checks. We help streamline your certification, registration, and ongoing compliance with expert guidance and tailored support.
Phoebe.
Documentation Check
Hello, I’m Phoebe, and I specialize in documentation review and optimization for medical device regulatory compliance.
Through my Documentation Checker service, I ensure your quality and regulatory documents—such as SOPs, technical files, and reports—are aligned with MDR and ISO 13485 expectations, clear, grammatically correct, and overall structure. I handle all files in a GDPR‑compliant way and, where needed, can also flag obvious gaps related to GDPR in your procedures (for example, data protection wording in patient‑facing documents). My goal is to help you communicate your compliance confidently and effectively, making audits and submissions smoother for your team.
+31 6 842 71966
Daniel.
Registration Dossier Check
Hello, I’m Daniel, your expert in regulatory dossier reviews for multiple countries.
With my Registration Dossier Check service, I carefully evaluate your submission files to ensure they meet the specific requirements of each target authority. I focus on structure, completeness, and consistency so that you can identify gaps early, improve accuracy, and increase your chances of smooth, timely approvals. Let me simplify your registration process and help you gain market access confidently.​
+31 6 429 4870
Clara.
Consistency & Traceability Check
Hello, I’m Clara, and I check the consistency, traceability, and risk story behind your documentation set.
I follow the links between your risk management file, GSPR matrix, IFU and labelling, clinical evaluation, and PMS/PMCF documents to spot misalignments, missing links, and conflicting statements. My goal is to make sure your safety narrative is clear, traceable, and audit‑ready across all documents, not just within each file.
+31 6 842 71966