In Life Sciences and Medical Device industry, rapid pace of scientific and technological advances have resulted in a great number of ground-breaking surgical, therapeutic and diagnostic possibilities for surgeons and patients worldwide. Afxisi can help you meet your business objective through our strategic, innovative and cost efficient solutions.

Client Challenges

• Reducing time-to-market span and manage an increased product portfolio
• Optimizing expenditure on New Product Development
• Enhancing operational efficiencies
• Managing supply chain complexities effectively
• Complying with complex regulatory processes

What Afxisi Provides

Afxisi’ Engineering and Industrial Services (EIS) has competencies across the product life cycle, from concept to commercialization, manufacturing, post market surveillance to end of life management. Our key offerings are:

• Engineering Services: New Product Development (NPD); Mechanical Systems Design; Electro-Mechanical Design; Embedded Electronics Software; Prototyping; Plastics Engineering; Sustaining Engineering; Value Engineering; Materials Research and R&D Services.
• Technology Solutions: Product Lifecycle Management (PLM); Enterprise Asset Management (EAM); Plant Automation Solutions (PAS); Manufacturing Execution Systems (MES); CAD / CAM / CAE; Radio Frequency Identification (RFID); Clinical Trials Support.
• Manufacturing Solutions: Enterprise Manufacturing Intelligence; Integrated Production Management System; Process Optimization and Analytics; Automation Solutions; Pharmaceutical Manufacturing IT Services; Plant Engineering; Strategic Sourcing.
• Regulatory Compliance: FDA ‘21 CFR Part 820’ and ‘21 CFR Part 11’; EU MDD (CE); MHRA (Medicine and Healthcare Regulatory Agency); Design Control (Class I, II and III) and Manufacturing Control; eDMR /eDHF /eDHR; CAPA (Corrective Action Preventive action); Recall Readiness; Traceability; LIMS (Laboratory Information Management System).

Business Value

• Higher return on investment (ROI)
• Reduced time-to-market
• Reduced risk with compliance in New Product Introduction (NPI) and Manufacturing
• Higher asset utilization by integrating plant layer with enterprise systems
• Optimization of manufacturing processes leading to process improvements