Theresa is Head Combination Products at SFL.

Theresa is a well-recognized medtech expert with extensive knowledge in the development of combination products. Under Theresa’s leadership, the SFL team will support clients developing and manufacturing combination products to ensure continuous marketing of their products.

Theresa has over 25 years experience working in the Notified Bodies, Medical Device as well as Pharmaceutical industries. Before joining SFL; Theresa was Head of a major European Notified Body and performed many conformity assessments of medical devices, IVDs and medical devices containing ancillary medicinal substances / human blood derivatives and conducted consultation process with EU Competent Authorities as well as management of the conformity assessment process and CE Certification decisions. Theresa is also an EU certified lead auditor and is a regular speaker on the implementation of the new Regulations.

Theresa supports borderline classification, devising and implementing regulatory strategies for regulatory submissions for CE mark and has a great deal of experience interacting with a number of regulatory bodies, compiling technical files and design dossiers. She gained FDA approval for drug delivery devices and has also obtained the CE mark for Class III devices, containing ancillary medicinal substances and utilizing animal tissue. In addition to her product expertise she also has extensive Quality Management System expertise covering all aspects of developing, training, implementing, and maintaining ISO 13485 certification for medical devices and Good Manufacturing Practice for medicinal products.

Theresa holds a MSc in Pharmaceutical Technology from the Royal College of Surgeons, Ireland which makes her eligible for pharmaceutical Qualified Person status.

She is an active member of the TOPRA SPIN Committee for Medtech and regular contributor to “Regulatory Rapporteur”.