Representing our 11-member team of experts, you can see below the main contact partners for your projects:
Dr. rer. medic. - Lead Project Manager
Lead Quality Manager
FDA Compliance, 510(k), Premarket Approval (PMA) Human Factors Studies, CSP, CSR FDA 21 CFR Part 820 ISO standards, e.g. 9001, 13485, 19011, 60601, 62366. Usability, Medical Devices, GLP, GSP, GDP (documentation) PMS, PMCF, e.g. incidents, MAUDE, PUBMED, etc. Certification Process: Preclinical development, regulatory strategies Project Management, QMS, internal Audits, Notified Bodies, Competent Authorities, IRBs/Ethics Committees, DIMDI MDR, Clinical Evaluations of Medical Devices, MEDDEV 2.7/1 Rev 4 Risk Management, FMEA IVDR, Performance Evaluations, Market Survey & Analyses FDA 21 CRF Part 11, ISO standards, e.g. 17025, 27001, 62304 etc. Market Authorization Process: Product registration, CE Compliance, UDI, Literature & databases searches DHF, DHR, DMR, Technical Documentation, Inspection & Audits, e.g. FDA, Brazil, Russia, MDSAP clinical trials, ICH GCP, GMP, GxP. Clean room & Sterilization, Radiation protection, Data protection, Occupational Safety, QMR, Medical Writing, Medical Device consultant according to 31 MPG Validations & Qualifications, Food Supplements, Novel Food IATF 16949, ISO 14001, 14155, 15224, 50001, 9100. Regulatory process: clinical development, training & seminars. Etc.