Medical Device
The current trend of consolidation within the Medical Device industry is capturing the attention of the FDA. Companies are getting larger and thus more visible to the FDA. Compliance requirements are rapidly increasing as smaller, less sophisticated manufacturers are consolidated into larger and larger companies. Maetrics™ has been working with Fortune 500, as well as small and mid-size Medical Device manufacturers since our inception in 1984. We understand the unique compliance and quality requirements of the industry. Manufacturers are discovering that validation requirements are becoming more and more rigorous, requiring a look at current validation practices for manufacturing facilities, device master/history files and technical files, combination products, as well as laboratories (test methods & equipment), clean rooms, utilities, software, and product/processes. Our experience in this industry is extensive. We can rapidly assess your needs and provide the necessary assistance to help you avoid unacceptable compliance risk.
- Our Approach / Our People
- Project-based Services
- Experience / Program & Project Management
