2 0+ YEARS EXPERIENCE IN MEDICAL DEVICE BUSINESS FOR: • New Product Development • Design Control • Regulations (ISO 13485, MDR, ISO 14971, FDA 21 CFR 820.30, ect ...) • Technical Project Management WE OFFER SERVICES FOR: • Product Development: Project Management, technical documentation and remediation actions • Project assessment for both start-ups and well established companies • Temporary management of R&D and QA&RA • Technical tutoring and mentoring for new managers in R&D and QA&RA TRAININGS IN AREAS SUCH AS: • New Product Development • Medical devices • R&D • QA&RA (Quality Assurance and Regulatory Affairs) We work with partners in the areas of mechanical engineering, IP, strategic marketing, project financing initiatives and process validation.