Medical Device & QA

Are you working within the medical device or IVD area? Pharma4ever QA is the ideal choice if you’re working on a tight schedule, or need specialist competencies. 

• Pharma4ever QA provides specialist assistance in the following key areas:
• Authority Legislations e.g. EU, US, JP, CMDCAS
• Quality Management System, ISO 13485, ISO 9001
• Regulatory Expertise within MDD/MDR, IVDR, MDSAP, FDA, cGMP
• Risk Management Processes according to ISO 14971:2019
• Biological Evaluations
• Clinical Evaluations
• Statistical Disciplines
• Design Control incl. DHF establishment
• Device & Equipment Qualification and Validation
• Usability Engineering
• Internal and External Audit Performance
• Supplier Management
• Education & Training Programs

With solid working experience in each of the areas listed above, we are committed to help you achieve the best possible results within these core disciplines, and any corresponding fields.