I began working with Neasa as a Consultant in November 2014 as Cosmo Pharmaceuticals was preparing to develop an ISO 13485 / CFR 21 Part 820 Quality Management System in order to support the design, manufacture, marketing approval and distribution of medical device products. Cosmo needed a Quality and Regulatory expert within the medical device industry to develop the QMS, train Cosmo staff on the requirements and regulations and support the submission of our devices for 510(k) and CE Mark approval.
Over the course of our working relationship, Neasa has been our regulatory and quality Subject Matter Expert in relation to Medical Devices in particular, and the QMS in general. She supported Cosmo extensively in the building and improvement of the QMS and works with our quality team to continuously improve it and ensure its effective implementation. She is also our lead auditor who is responsible for the execution of our internal audit program and she conducts all our supplier quality audits, including on-site audits of critical suppliers. In 2018 we joined the MDSAP audit program.
Neasa worked alongside the Cosmo quality team to upgrade the QMS to ensure audit-readiness. Her support was invaluable in achieving a successful MDSAP audit outcome. Neasa works well with our quality team, suppliers and external Notified Bodies and I know I can rely on her to support us when urgent matters arise. I highly recommend Neasa as a Quality and Regulatory expert. She has a highly professional approach, a great level of knowledge and a practical approach to problem solving and is a pleasure to work with.Cosmo Pharmaceuticals, Clinical R&D Manager and Management Representative (Quality Assurance Medical Devices)