Tammy Robinson

Background

About Tammy Robinson

Career professional of over 30 years (15 years in medical device and additional 15 years in engineering). Medical device experience (industry and auditing) includes active non-implantable, active implantable, non-active implantable, medical devices incorporating medicinal substances, medical devices utilizing tissues of animal and human derives, reusable surgical instruments, devices controlled by software, devices with measurement functions, devices for wound care, non-active dental devices, devices for radiation therapy, and IVD medical devices. Possess extensive knowledge and experience in Quality Management Systems including product technical documents with regulatory requirements of ISO 13485, FDA 21 CFR 820, EU regulations MDD 93/42/EEC, AIMD 90/385/EEC, MDR 2017/745, UK (Part II of Medical Devices Regulations 2002), MDSAP (USA (21 CFR 820, 803, 806, 807, 821), Australia (Therapeutic Goods MD Regulation 2002), Canada (SOR 98/282), Japan (MHLW 169), Brazil (RDC ANVISA n.