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 ManagementWE 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&RATRAININGS 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.