Pharmalex Medical Device Services

CONTACT US TODAY at meddevice@pharmalex.com Safis Medical Device Services is a Regulatory, Quality & Compliance Consulting and Outsourcing Firm. Dedicated to Building partnerships with our Medical Device clients and focusing on Patient Safety and the advancement of Healthcare. Safis was founded in 2002 and joined PharmaLex Company in 2017 becoming part of a global team of RA/QA professionals across Life Science Industries with 31 offices across the world and over 600 employees. Safis Medical Device Services employs RA/QA professionals with extensive global Medical Device experience. Consulting product offerings include End to End customized services in the areas of Pre-Market RA (regulatory strategy development, product submission, IDE submission, etc), QA/Compliance (compliance strategy and quality plan development, gap assessments and quality auditing, QMS development/revision), Product and Process Remediation (project planning, workstream leadership and support, Regulatory Agency interfacing/correspondence, Inspection readiness), and Culture Transformation. Outsourcing solutions include RA and QA Maintenance Services, Interim Staffing, Post-Market Surveillance Reports, Employee Training, Quality Auditing, Regulatory Intelligence Monitoring/Reporting and Due Diligence for Acquisitions.