Exhibitor Application

Jan Triani

Jan Triani, Founder of Triani Consulting, has more than 20 years of experience in the medtech industry and has worked with companies at various development stages. She has experience in FDA Audits, has led front rooms in five FDA QSITs and authored two Quality Management Systems for startups. She has also led Stage I/II assessments with BSI, achieved ISO 13485 certification, managed annual audits and overseen Complaint Handling and CAPA teams. Jan’s regulatory affairs and compliance experience includes advising teams on regulatory strategies, developing biocompatibility, sterilization and packaging test strategies for Class II devices, managing regulatory affairs and quality assurance teams, authoring 510(k)s, HDE, Compassionate Use and IDE submissions, and handling 483 and Warning Letter responses. Jan is a Medical Advisory Board Member at AddUp and was previously the Director of Quality Assurance and Regulatory Affairs, Patient Specific at Paragon 28 and Senior Director of Quality Assurance and Regulatory Affairs at Onkos Surgical.

Sessions from this speaker
Today
  • FDA Regulatory Tools

    Speeding Innovation Through Streamlined Regulatory Tools

    FDA has new approaches to navigating the complex regulatory landscape and systems in place to remove the burdens of securing marketing clearance for innovative devices that promise to improve patient care.