Sarah Cowlishaw

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 London and Dublin practicing in the areas of EU, UK and Irish life sciences law. 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 on:

• obligations under the EU Medical Devices Regulation and In Vitro Diagnostics Medical Devices Regulation, including associated transition issues, and UK-specific considerations caused by Brexit;
• medical device CE and UKCA marking, quality systems, device vigilance and rules governing clinical investigations and performance evaluations of medical devices and in vitro diagnostics;
• borderline classification determinations for software medical devices;
• legal issues presented by digital health technologies including artificial intelligence;
• 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.