Niels Ole Andersen is a Regulatory Expert within Medical Devices based on extended experience with regulatory compliance for devices and software/apps used within Homecare, Telehealth, Telemedicine and Mobile Healthcare. This includes product certification according to MDD in Europe and FDA clearance according to FDA 510(k) in USA.
Experience with Pragmatic Compliance that is essential to establish a competitive market driven regulatory strategy.
Experience implementing and being responsible for Quality Assurance Systems certified to ISO13485 and compliant to FDA 21CFR820, used to develop, manufacture and deliver medical devices and software/apps in both small and larger organisations. This includes certification audits, FDA inspection, EU National Competent Authority inspection and audits done by international customers.
Many years’ experience being Development Manager and Project Manager in Medical Device development projects performed according to medical quality assurance systems, and obtain final product compliance to the Regulatory Requirements.
Experience with Medical Device regulatory requirements regarding Data Privacy and Data Security related to the Data Protection Directive in EU and HIPAA/FDA in USA.
Updated with knowledge required to establish compliance to the new Medical Device Regulations for EU (2020) and the new Data Protection Regulation for EU (2018).