Health technology companies have always been an important customer for DRA. To better meet the needs of our customers and ever-increasing regulatory requirements on the field, DRA strengthens its expertise on the field of medical devices (MD or IVD).
Tiina Riihimäki, PhD (Medical Technology), has been appointed as Health Technology Team Leader at DRA.
“We are extremely happy to welcome a highly experienced professional like Tiina to lead our Health Technology team,” says Unit Head Eija Kinos. “Tiina has more than 15 years of experience in the field of Health Technologies, including conformity assessment of medical devices as well as experience on scientific medical technology research and industry operations,” Eija lists.
Before joining DRA, Tiina has worked at a notified body in both Finland and Sweden under different legislations (EU MDD , EU IVDD, EU MDR). She has worked as a lead auditor for MD/IVD products and for the standards ISO 13485/ISO 9001. Her latest position at a notified body was a combined role Technical Planning Specialist/Technical Documentation Assessor. Due to her expertise, she also held two subject matter expert positions for special areas (non-active wound and skin care products and pre-clinical evaluation (biological safety).
In addition, Tiina has experience from the pharmaceutical industry, working in the Medical Device Quality&Vigilance lead role in Pharmaceutical company. Besides that, she has provided QMS training to Health Technology companies.
“Thanks to my versatile professional background, I have a clear vision of Health Technology companies’ current situation and the challenges posed by the new EU MD and EU IVD regulations,” Tiina points out. “I am looking forward to utilize my previous notified body work experience to enrich the medical device service offering at DRA. We can now provide even more comprehensive service to companies working in the Health Technology sector.”
DRA’s health technology team has expertise on medical devices (MD, IVD) on both Finnish and global markets covering the entire life cycle. Our service selection also includes training. Read more about our health technology services.