Overview

• Medtec Solutions S.R.L. is a staffing and recruiting company founded in 2023, headquartered at 15 Strada Mihai Eminescu, Vatra Dornei, Suceava County, Romania, 725700
• Specializes exclusively in medical device industry recruitment, leveraging years of team experience in regulatory and technical domains
• Operates with a small team of 3 employees focused on connecting organizations with consultants in cardiology, ophthalmology, gynecology, and urology specialties
• Targets highly regulated medical technology sectors requiring expertise in EU MDR, FDA 510(k), and ISO 13485 QMS compliance
• Serves clients needing talent for medical device sterilization, IEC 60601 standards, and risk management per ISO 14971

Specializations

• Medical Device Regulatory Compliance (EU MDR, FDA 510(k) submissions)
• Medical Device Quality Management Systems (ISO 13485 QMS implementation)
• Medical Device Engineering (IEC 60601 electrical safety standards, IEC 62304 software lifecycle)
• Medical Device Clinical Specializations (Cardiology, Ophthalmology, Urology device expertise)

Services & Approach

• Recruitment of Regulatory Affairs specialists for MDR transition and FDA compliance
• Talent acquisition for QA/QC professionals with ISO 13485 and sterilization validation experience
• Staffing of R&D engineers proficient in IEC 62366 usability engineering and design controls
• Placement of clinical affairs experts in performance qualification (PQ) and operational qualification (OQ)