With nearly 30 years of experience in quality and regulatory affairs, Teresa has been instrumental in shaping the industry.

Her career spans pivotal roles in securing accreditations, influencing regulatory policies, and guiding manufacturers through some of the most complex transitions in medical device history.

Key Achievements

LNE-GMED UK: As Head of Approved Body, Teresa led a dedicated team in implementing ISO/IEC 17065 and ISO/IEC 17021-1, securing critical designations under UK MDR 2002 Parts II, III, and IV. Through collective expertise and commitment, they enabled UKCA marking for both medical and non-medical products.

Regulatory Leadership: Teresa’s guidance positioned LNE-GMED UK as a founding member of Team-AB, shaping UK regulatory policies and achieving critical location status for GMED. She also facilitated the first-ever Innovative Device Access Pathway (IDAP) assessment in collaboration with the MHRA.

BSI: During her 20-year tenure at BSI, Teresa held key operational and leadership roles in auditing, CE Mark ophthalmic scheme management, certification, and global management. She was at the forefront of major regulatory shifts, including MDR, IVDR, MDSAP, and COVID-19 business continuity planning.

Industry Experience: Teresa’s hands-on experience in the contact lens manufacturing sector during the introduction of the original Medical Device Directive gives her a unique perspective on the challenges manufacturers face.