About Yumiko
Expert MDR Technical Documentation for Dental Manufacturers
With over 20 years of experience across dental practice, medical device companies, and Notified Bodies, I provide strategic MDR compliance support combining clinical insight, regulatory expertise, and assessor-level technical documentation review.
How I Help & The Value I Bring
MDR compliance for dental devices requires more than documentation - it requires structured regulatory argumentation aligned with Notified Body expectations. Having supported hundreds of manufacturers and assessors, I deliver precise, practical, and regulator-aligned guidance to help dental innovators achieve compliant and efficient EU market access.
MDR Compliance Services
- Pre-NB Documentation Stress-Testing: A rigorous readiness review of your technical documentation before submission to identify gaps and non-conformities from an assessor’s perspective.
- Technical Documentation & CER Development: Creation and updating of MDR-compliant technical files, including Clinical Evaluation Reports designed to withstand Notified Body scrutiny.
- PMS & PMCF Systems: Development of Post-Market Surveillance processes, PMCF plans, vigilance systems, and ongoing compliance frameworks.
- Regulatory Strategy & NB Query Support: Strategic planning and structured responses to Notified Body questions to reduce delays and non-conformities.
Why Manufacturers Choose This Approach
- Profound Clinical Insight: Clinically relevant risk assessments, usability justifications, and CER conclusions aligned with real-world dental practice.
- Insider Regulatory Expertise: Guidance structured according to assessor expectations—reducing follow-up questions and review cycles.
- Robust Technical File Architecture: Higher-quality Annex II & III submissions designed to withstand Notified Body scrutiny.
Ready to secure your market presence?
Book a free 30-minute MDR consultation to discuss your project.
English
Fluent
Japanese
Native or bilingual
Can work on-site
London (up to 50km)
Experience
- YK Dental ConsultancyConsultantCONSULTING AND AUDITSDecember 2025 - Today (6 months)London, UK- Strategic advisory: Providing expert guidance on EU MDR (2017/745) compliance, specifically for dental and surgical instruments.- Technical documentation: Delivering comprehensive gap analysis and pre-assessment reviews of technical files and clinical evaluation reports (CER).- Market access: Supporting manufacturers in aligning legacy products with current regulatory expectations to ensure seamless market transitions.
- IntertekClinical Specialist / Technical Documentation AssessorCONSULTING AND AUDITSDecember 2021 - March 2025 (3 years and 3 months)Milton Keynes, UK- Technical Assessment: Executed technically precise reviews of technical and clinical documentation for dental devices and surgical instruments under MDD and EU MDR for 30+ global clients.- QMS Optimisation: Evaluated and enhanced the QMS to integrate industry best practices and ensure full alignment with evolving internal and external requirements.- Project Leadership: Led a clinical assessor monitoring project, reviewing 20+ clinical assessment reports to ensure rigorous compliance with EU MDR.- Quality Assurance: Executed annual internal audits to verify regulatory compliance and assess process effectiveness; delivered targeted clinical assessment training to 20+ assessors.- Expert Guidance: Provided specialist regulatory training on dental devices under EU MDR on more than 10 occasions annually.
- SGS United KingdomProduct Assessor / Quality, Technical & Training CoordinatorCONSULTING AND AUDITSMarch 2014 - November 2021 (7 years and 8 months)Ellesmere Port, UK- Technical Review: Executed comprehensive technical documentation reviews for dental devices in accordance with MDD and relevant standards for 20+ clients.- Capacity Building: Designed and implemented a global training framework, enabling 80+ auditors and product assessors to obtain professional qualifications without compromising quality.- Technical & Regulatory Approval: Evaluated medical device questionnaires, proposals, and sampling plans; reviewed vigilance reports per MDD, ISO 17021 and ISO 13485.- Vigilance & Complaint Management: Managed 400+ medical device complaints and compliance investigations, ensuring prompt resolution under ISO 17021 and MDD/IVDD (98/79/EC).- Document Control: Acted as Document Controller, managing 70+ global/local documents; authored, revised, and maintained QMS SOPs for medical device certification.- Financial Reporting: Delivered precise quality and financial analysis to support strategic planning and management of financial operations.
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Education
- Doctor of Dental Surgery (DDS)Okayama University2000Doctor of Dental Surgery (DDS)
Certifications
- Dental Practitioner's LicenseMinistry of Health, Labour and Welfare2000
- IMNB - MDR - Technical Documentation RequirementsIntertek2022