The medical device industry is rigidly regulated as manufacturers of tools that support the healthcare industry. SAGE has worked with leading diagnostic and combination medical device manufacturers that produce cutting-edge technology for molecular testing and drug delivery systems.
Our expertise in the regulated industries and knowledge of complex manufacturing and packaging processes allows us to develop robust and cost-effective solutions on Equipment & Facility Engineering, Compliance & Validation, and overall Project Management projects for our clients.
SAGE can provide the following services to support your medical device projects:
- Gap Assessment against regulatory requirements for lab equipment, commercial scale equipment, and facility systems including utilities and clean rooms.
- Remediation Strategy Development for compliance gaps
- Prepare User Requirements Specifications
- Prepare Validation Master Plan for Equipment and Facility
- Prepare and execute Commissioning and IOQ protocols
Equipment & Facility Engineering
Implemented solutions for a wide range of equipment and facility systems for combination medical device products
Redesigned a new configuration of biological laboratory space in order to create additional modular spaces for proprietary reactors and gowning areas to allow for segregated access to the new biological laboratory rooms
Compliance & Validation
Performed compliance audits against ISO 13485, Eudralex, WHO, 21 CFR Parts 210, 211, 820 and 11 for a new silicone drug delivery system
End to End
Developed an automated solution for a medical test cartridge assembly process, including process design, specification development, and vendor management