CONTACT US TODAY at meddevice@pharmalex.comSafis 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.

Life Sciences Medical Device Pharmaceutical Biotechnology IVD Diagnostic Regulatory Affairs Strategy/Submissions Quality Systems (International) Validation Qualification/Commissioning CSV Auditing Vendor Assessment/Selection Medical Devices Pre-Market RA QA & Compliance Quality Auditing QMS Development/Revision Remediation Post-Market Surveillance Technical Files/CE Marking CERs Employee Training Organizational Design Culture Transformation Quality Metrics Regulatory Intelligence Regulatory Agency Interfacing/Responses Inspection/Audit Readiness RA Maintenance Services QA & Compliance Medical Equipment Medical and Hospital Equipment