Bergenthal Consulting

• product submissions (e.g. fda 510(k) or ce marking) • review of technical documentation (e.g. sted or eu mdr) • risk management according to iso 14971 • software development according to en 62304 and en 82304-1 • artificial intelligence (ai) and machine learning (ml) • software as a medical device (samd) and software as a service (saas) • cloud and mobile devices • process optimizations and process interfaces across the quality management system (qms) • document control • internal and external audits like eu mdr, mdsap, or fda inspections (frontroom/backroom) • supplier management and supplier audits • corrective and preventive actions (capa) • remediation • tool validation • complaint handling and vigilance • field actions and recalls • non-conformities • quality management representative (qmr) and person responsible for regulatory compliance (prrc) • project support and planning