Have You Thought Of Everything?
Development pathways in the Medical Devices industry are unique and require specific expertise and knowledge. Our consultants have the specialized expertise you need to be successful in this space. In the R&D stage for example, engineers need to operate with speed and flexibility. NovusLife can help you establish a lean quality system to support new product design and grow the system as the design matures and additional controls are required. Delaying quality system implementation can be costly. NovusLife can provide quality support through the early phases to limit exposure worldwide. We can assist companies through the transition phases, providing the extra resources needed to grow, improve and maintain the quality system.
Struggling to address non-compliance as identified in the quality system? Have a backlog of CAPA, complaints, audit responses, nonconformance dispositions? NovusLife has skilled and experienced Quality professionals ready to support all your Quality needs.
ISO 13485 Quality Management System Design and Maintenance
CAPA and Complaint Management
Internal and Supplier Auditing (GXP)
Warning Letter Remediation