DeviceAdvisors, LLP
Medical Device Consulting Services
Quality/Regulatory Product Development Intellectual Property
OUR SERVICES
Consultation
● chemicals and polymer materials for use in devices
● material properties and requirements, criteria for selection
● vendor alternatives, selection and qualification
● device design and development
● development of materials and devices manufacturing processes
● technology feasibility and fit with intended use
● patent landscape assessment, patentability evaluation
● patent searching and freedom-to-operate analyses
Guidance
● materials testing and qualification
● vendor qualification and certification
● combination product requirements – development and manufacturing
● quality system development
● design controls and compliance
● resolution of regulatory issues
Assistance
● qualification of materials suppliers
● in-coming material qualification
● selection of appropriate testing laboratories
● understanding worker safety requirements in chemical environments
● development of suitable chemical waste handling procedures
● design of relevant safety studies for materials and devices
Documentation and Training
● quality system requirements
● design control principles and procedures
● cGMP requirements for devices
● safe handling of chemical materials, pharmaceutical materials
● facility registration requirements and strategies
● ISO standards and qualification
● OSHA and EPA regulations for chemical environments