Advising clients on a broad range of life sciences matters, Sarah Cowlishaw supports innovative pharmaceutical, biotech, medical device, diagnostic and technology companies on regulatory, compliance, transactional, and legislative matters.

Sarah is a partner in Covington’s European Life Sciences practice. She has particular expertise in medical devices and diagnostics, and on advising on legal issues presented by digital health technologies, helping companies navigate regulatory frameworks while balancing challenges presented by the pace of technological change over legislative developments.

Sarah is a co-chair of Covington’s multidisciplinary Digital Health Initiative, which brings together the firm’s considerable resources across the broad array of legal, regulatory, commercial, and policy issues relating to the development and exploitation of digital health products and services.

Sarah regularly advises companies (from big multinationals through to early-stage start-ups) on:

obligations under the EU Medical Devices Regulation (EU MDR) and In Vitro Diagnostics Medical Devices Regulation (EU IVDR), and equivalent obligations under the UK-specific framework resulting from Brexit;
medical device CE and UKCA marking, quality system requirements, device vigilance and rules governing clinical investigations and performance evaluations of medical devices and in vitro diagnostics;
borderline classification determinations, including for software medical devices;
legal issues presented by digital health and artificial intelligence technologies;
general regulatory matters for the pharma and device industry, including borderline determinations, adverse event and other reporting obligations, manufacturing controls, and labeling and promotion;
the full range of agreements that span the product life-cycle in the life sciences sector, including collaborations and other strategic agreements, clinical trial agreements, and manufacturing and supply agreements; and
regulatory and commercial due diligence for life sciences transactions.

Sarah has been recognized as one of the UK’s Rising Stars by Law.com (2021), which lists 25 up and coming female lawyers in the UK. She was named among the Hot 100 by The Lawyer (2020) and was included in the 50 Movers & Shakers in BioBusiness 2019 for advancing legal thinking for digital health.

Sarah is also Training Principal for Covington’s London office.