Casey Sedgwick
Business Development Manager @Regulatus Ltd
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WORK HISTORY
Business Development Manager @Regulatus Ltd
GB
Business and customer development manager for Regulatus, The Science of Compliance. Supporting and developing Regulatus to offer the best services within QA, RA, Sterilisation, manufacturing, UKRP services and beyond for Medtech companies including Medical device, diagnostics and IVD’s, cosmetics and pharmaceuticals as we navigate the complex Regulatory landscape of the Life Sciences industry. Offering tailored and confident approach to training, learning and compliance support, you can reach out to us with any queries as you evolve.
EDUCATION
The University of Huddersfield
Bachelor's degree, Journalism
ABOUT CASEY SEDGWICK
As part of IVDeology, my focus is connecting IVD companies to flexible, compliant and supportive compliance specialists here at any stage of the journey you are at, whether you’re a team of 2 or a team of 200, Quality and regulatory compliance is a key part of getting your IVD and medtech devices on the market and changing and improving peoples lives. IVDeology is a growing business of like-minded, friendly professionals who are passionate about Regulatory affairs and Quality compliance specifically within the in vitro diagnostic medical device industry. Our team have been curated and is made up of industry professionals from companies such as Thermofisher to Abbott diagnostics, we are a hands on, knowledgeable team are offer personalised plans from building regulatory strategies, technical file review and builds, QMS implementation and maintenance, and accelerating you onto worldwide markets Other areas of support include: • IVDR CE Marking (IVD Regulation 2017/746/EU) • UKCA (MDR 2002) • Quality Management Systems (ISO13485) • Risk Management (ISO14971) • MDSAP (Medical Device Single Audit Programme) • IVD Technical Documentation • IVD Packaging and Labelling, Instructions for Use • Performance Evaluation Reports Scientific Validity Reports • IVD Project Rescue We can also deliver training and workshops, as well as hosting complementary webinars that fit your specific needs to benefit you the best If you are looking for IVDR support please get in touch on i•••@ivdeology.co.uk or message me! I\'d be happy to help
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