Meet our expert Christine Öberg
Since her start in 2018, Christine adds extra colour to SDS´ evolving Medical device-team. With seven years of robust knowledge and glowing energy, she assists companies to develop and maintain Quality Management System as well as products in compliance with regulatory regulations. Her strength is to develop Standard Operating Procedures and work instructions that are easy to follow.
As leader of risk evaluation activities, she is accustomed to working on cross-functional risk analysis teams. She has performed in both internal and external audits.
Furthermore, she has implemented system for an electronic document management system in accordance with ISO13485 and FDA CFR part 11.
“Right now, the medical device field is in an exciting but challenging phase with the transition to the new MDR and IVDR. I am happy to guide clients in their effort to adapt their QMS and product documentation to the new regulations.”
Call us if you want to comply with the medical device regulations!