Joakim Arwidson

Background

About Joakim Arwidson

I have 29 years of experience in life sciences including medical devices, biotech and diagnostics industries, of which 18 years in management and executive positions. Responsible for management of several succesfull pre-market notifications for medical devices and IVDs' in the U.S, Canada, EMEA and APAC like 510k (K202852, K202882, K193152, K191216, K181468, K171719, K171681, K163687, K163394, K153056, K142631, K140269, K131233, K121278, K033550), Canada Health (MDL, MDEL), China (CFDA / CQC) and MPA (Intertek). Responsible for QMS certifications and audits according to the following regulations and standards IVDR 2017/746, MDR 2017/745, MDD/93/42/EC, IVDD 98/79/EC, ISO13485:2016, MDSAP (Canada/US), ISO9001, ISO27001 (incl. HIPAA/PIPED/GDPR) QSR, MHLW and CFDA/CQC. During 2010 - 2021 also responsible as Data Protection Officer at Hermes Medical Solutions including implementation of HIPAA, GDPR procedures and ISO27001. Different kind PII including PHI and PACS services to customers. Responsible for BAA / DPA agreements with major customers (e.g, IDNs, DoD, Veterans in U.S, NHS/UK) and suppliers for co-location and cloud services. Long experience of management/development of biomarkers (IVDD, IVDR, CLSI standards, LTD/US, CLIA and CAP accreditation), and molecular imaging for post processing, flourscopy, bone densitometry (dual x-ray and laser) in accordance to regulatory standards as MDR, ISO14971, IEC62304, IEC62366, 60601-1, and collateral standards for x-ray equipments. Experience of international marketing, sales and branding. Used to do presentations for opinion leaders and other VIPs.