Boston An independent LDT provider

Annika Andersson

QA/RA Director

Annika Andersson is a Biomedical Scientist from Malmö University. She has more than 25 years’ experience within the life science and diagnostics industry, with the main focus on regulatory affairs and quality assurance of in vitro diagnostic medical devices. Annika contributes with global experience within regulatory strategies and regulatory submissions of IVDs. Her track record includes leading successful regulatory approval processes of medical devices for IVD CE marking as well as IVD approvals in Canada, China, India, Japan, Korea, Mexico, Russia and 510(k) clearances in the USA.

Current assignments: None.

Previous assignments (past five years): Leading position at Euro Diagnostica AB (now SVAR Life Science AB).