Therese has more than 15 years experience in the Medical Device industry. She has an engineering background (1999) and a Master in Quality Management and Leadership (2013). Therese has support several business organizations with regulatory and Quality compliance for medical device products. She has work as Quality and Regulatory Manager for class III Medical device and have previous work in Quality and regulatory departments for different Medical Device businesses. She support companies with compliance towards MDD (93/42/EC) and IVDD (98/79/EC). She has help several companies reach their ISO 13485 certificate, and has a Lead Auditor training. She also acts as a facilitator in Risk Management (ISO 14971) and CAPA-management (root cause analysis etc). She has been involved in cross-functional teams for R&D projects and responsible for regulatory compliance, for Technical documents, as for example “Medical DEvice Classification”, “Essential Requirement checklist”, “Harmonized standards”, “Declaration of Conformity” etc.