I began working with Neasa in November 2017 as Design Partners were investigating some changes to our Quality Management System. She supported us to update our Quality Manual to comply with the 2016 revision of the ISO 13485 standard.
Neasa worked with our Healthcare and Science team to brainstorm our annual 2018 quality objectives and provided guidance on how to set realistic quality KPIs that would help us to drive improvement and efficiencies. She drafted a number of new procedures and supported what we call a “Quality System Re-Set”.
We continue to work together as Neasa is our internal auditor lead and supports us with medical device regulation and industry trend training. Based on my experience, I consider her to be an expert in medical device standards and requirements who is able to find company-specific solutions to ensure compliance. I have no hesitation to recommend Neasa as a quality and regulatory consultant for any company working in the medical device innovation sector.
Design Partners, Quality Manager