"Think like a regulator.."
Device Advice & CERs is located in Brisbane, Australia. The company founder, Daniela Sanders, saw a need in the medical device industry for experienced Regulatory Affairs consulting to assist companies with a wide range of services.
From assisting small start-up companies with one product, to her experience in a large medical device firm with over 3,000 devices, she believes her services can benefit a wide range of companies. She also believes that in order to gain regulatory approvals that it's important to "think like a regulator" and her experience working at the FDA and with the TGA and European Notified Bodies has helped her do just that!
The founder and CEO of Device Advice & CERs, Daniela Sanders, has been working in the healthcare industry since 1989. Previously she worked as a Senior Regulatory Affairs Specialist for 12 years. Prior to this she worked as a Safety Evaluator at the FDA (CDER - Office of Drug Safety). With her training and hospital experience as a Clinical Pharmacist and previous roles within drug companies, she has developed advanced skills in written communication with a depth of understanding which has lead to numerous successful regulatory submissions and related correspondence.