Medical device management systems consultancy and engineering

Get your medical device ready for MDR and ISO 13485 audits

EUmediq supports medical device manufacturers directly on technical documentation, quality management systems and clinical evaluation.

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A technical document moves through classification, technical documentation, clinical evaluation, quality management system and notified body assessment, and is completed with CE marking.

MDR 2017/745 and CE markingFrom classification to the notified body certificate
ISO 13485 quality systemSet-up, internal audit and certification readiness
Drug-device productsExperience where device and medicinal law meet

Services

All services

MDR 2017/745 and CE Marking

Classifying your device under the EU Medical Device Regulation (MDR 2017/745), building the technical documentation, moving from MDD to MDR and managing the notified body process.

ISO 13485 Quality Management System

Setting up, documenting and preparing an ISO 13485:2016 quality management system for certification. Internal audits, management review and processes aligned with the MDR are included.

Clinical Evaluation, PMS and PMCF

Preparing the clinical evaluation report (CER) in line with the MDR and MEDDEV 2.7/1 rev. 4; post-market surveillance (PMS) plan and reports, PSUR and post-market clinical follow-up (PMCF).

Vigilance

Reporting serious incidents to the competent authority on time, field safety corrective actions (FSCA), field safety notices (FSN) and trend reporting: setting up the system and supporting the reports.

Risk Management (ISO 14971)

Building the risk management file to ISO 14971:2019: hazard analysis, risk control measures, overall residual risk and benefit-risk evaluation, kept current with design, production and post-market data.

Validation and Sterilisation

Validation of manufacturing processes, sterilisation, cleanrooms and packaging: IQ/OQ/PQ protocols and reports, ethylene oxide, radiation and steam sterilisation, sterile barrier systems and shelf-life studies.

One consultant, from first meeting to closing the audit

EUmediq is the consultancy practice of Esra Gündağ in medical device regulation. The same person runs your project from the first meeting to the closing of the audit, so nothing is lost between teams.

Esra Gündağ looks at quality and regulatory work from the manufacturer’s side. A procedure has to satisfy the production floor as well as the auditor.

About

How the work runs

First meeting You talk through the device, its class, your target market and your timeline. What you need, and what you do not, becomes clear in this conversation.
Gap analysis Your technical documentation and quality system are compared against the applicable requirements. Gaps are reported in writing, in order of priority.
Implementation and audit Gaps are closed together and the documents are prepared. Support continues through the notified body audit and the closing of findings.

Seven-step flow: classification, technical documentation, clinical evaluation, quality management system, notified body assessment, CE marking and post-market surveillance. Post-market surveillance data updates the technical documentation.