Medical Device Consultancy Services
EUmediq supports regulatory and quality work from device design through to the post-market phase. Below you will find the scope of each service and when it is needed.
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.
Read the details: MDR 2017/745 and CE MarkingISO 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.
Read the details: ISO 13485 Quality Management SystemClinical 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).
Read the details: Clinical Evaluation, PMS and PMCFVigilance
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.
Read the details: VigilanceRisk 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.
Read the details: Risk Management (ISO 14971)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.
Read the details: Validation and SterilisationBiocompatibility (ISO 10993)
Biological evaluation plan and report to ISO 10993-1 for devices in contact with the body. Chemical characterisation, test strategy, managing the laboratory work and linking results to the technical documentation.
Read the details: Biocompatibility (ISO 10993)Marketing Authorisation and GMP
Preparing the marketing authorisation dossier (CTD) for medicinal and drug-device combination products and following the TİTCK process. Preparing the site, documents and quality system for a Good Manufacturing Practice (GMP) inspection.
Read the details: Marketing Authorisation and GMPSupplier Audits
Evaluating raw material, component, contract manufacturing and sterilisation suppliers against ISO 13485 and MDR requirements, auditing them on site and preparing quality agreements.
Read the details: Supplier Audits