Our team of experts is dedicated to providing tailored solutions that address the unique challenges of each industry, helping our clients to achieve their quality and productivity goals.
Scientific and Medical Devices
Scientific and Medical Devices
-
Quality Investigations resolution and backlog reduction
-
Risk management implementation and roll-out
-
Product development process and quality systems characterization and improvement, for instruments, reagents, consumables, panels and software
-
Product and process architecture diagrams
-
Cloud database design and application development, for data, risk and change management
-
Highly-visual procedures and training materials for increased quality in manufacturing floor
-
Manufacturing execution systems (MES) modeling and implementation support
Biotechnology and Combination Products
Biotechnology and Combination Products
-
Quality Investigations resolution and backlog reduction
-
Process characterization and mapping
-
Value stream mapping
-
Development of trainings material to prevent recurrence of non-conforming events
-
NDA submission documentation
-
Database development to support NDA submission
-
CAPA project management and execution
Surgical Robots
Surgical Robots
-
Quality Investigations resolution and backlog reduction
-
Risk management and process characterization
-
Risk-based improvements to manufacturing steps
-
UML activity diagrams for process characterization, manufacturing and software operations
Cell Therapy
Cell Therapy
-
Quality Investigations resolution and backlog reduction
-
Process characterization and value stream mapping, for manufacturing and supply chain
-
Highly-visual procedures and job aids for manufacturing, facilities, utilities and supply chain
-
Risk-based product development
-
Quality Investigations resolution and backlog reduction
-
Process characterization and value stream mapping, for manufacturing and supply chain
-
Highly-visual procedures and job aids for manufacturing, facilities, utilities and supply chain
-
Risk-based product development