With over 20 years of experience in the med tech industry, I have dedicated my career to working with companies at various stages, ensuring that people and compliance are at the heart of their operations.In Quality Assurance, I excel in FDA Audits (QSIT and Direct Inspections), have led front rooms in 5 FDA QSITs, and authored two Quality Management Systems for startups. I've also led Stage I/II assessments with BSI, achieved ISO 13485 certification, managed annual audits, and overseen Complaint Handling and CAPA teams.My Regulatory Affairs & Compliance experience includes advising teams on regulatory strategies, developing biocompatibility/sterilization/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.If you need to talk through regulatory strategy or need help with a specific compliance issue, then contact me via LinkedIn or email at jan@trianillc.com. I can help you on a project or hourly basis.