Medical Device Manufacturing
Medical technology is advancing at light speed: new products, and new manufacturing techniques unimaginable a few years ago. Our unique combination of technical expertise, manufacturing quality systems understanding, and customer business focus allows us to help you meet stringent compliance demands while delivering life-enhancing products to patients and profits to shareholders.Our 20 years of experience with current Good Manufacturing Processes, across all facets of manufacturing, enables us to be extremely reliable third party experts. We are actively involved in multiple industry professional societies at the local and national level, chairing committees, writing guidance documents, and taking leadership roles in evolving and streamlining processes and regulations. We exist to help our clients drive down their cost of goods and increase operational efficiency while continuing to provide the high-quality lifesaving products and freedom enhancing devices their patients need.
Representative clients
- Terumo
- Abbott Vascular
- Ethicon
- DePuy
- Boston Scientific
- Meridian Medical Technologies
Services
- Commissioning, Qualification, and Validation
- Process and Concept Design
- Capital Project Delivery
- Operations and Continuous Improvement
- Product Realization Consulting
- Quality and Regulatory Consulting
- Site and Manufacturing Operations Consulting
- Supply Chain Support
- Owner’s Project Management
- Early and Mature Asset Management
- Asset Performance Optimization
- Work Management Services
- Automation and Information Technology Services