Gard Consulting
Consulting firm focused on biomedical technology and medical device development. Services span feasibility studies, prototyping, design for manufacture, verification and validation, regulatory and quality-system support (including ISO 13485 and CE marking), and industrialization strategies through partnerships with certified manufacturers and research organizations.
Industries
Nr. of Employees
small (1-50)
Gard Consulting
Products
Medical Device Design and Development Consulting
Consulting service for designing and developing innovative medical devices from concept to market readiness.
Feasibility Studies and Preliminary Prototyping
Service to evaluate the viability of medical device ideas and create initial prototypes for testing and development.
Regulatory Compliance and In Vitro Testing Support
Support service ensuring medical devices meet FDA and ISO 13485 regulatory requirements through in vitro testing and quality processes.
Industrialization Strategy and Manufacturing Coordination
Service to develop industrialization plans and coordinate manufacturing of medical devices with qualified industry partners.
Medical Device Design and Development Consulting
Consulting service for designing and developing innovative medical devices from concept to market readiness.
Feasibility Studies and Preliminary Prototyping
Service to evaluate the viability of medical device ideas and create initial prototypes for testing and development.
Regulatory Compliance and In Vitro Testing Support
Support service ensuring medical devices meet FDA and ISO 13485 regulatory requirements through in vitro testing and quality processes.
Industrialization Strategy and Manufacturing Coordination
Service to develop industrialization plans and coordinate manufacturing of medical devices with qualified industry partners.
Services
Medical device R&D consulting
Consulting across concept validation, design, prototyping and specification for medical devices.
Feasibility studies and prototyping
Feasibility assessments and preliminary prototype development to de-risk concepts before detailed design.
Design for manufacturing and industrialization planning
Development of manufacturing process specifications and industrialization strategies with certified industry partners.
Regulatory and quality system support
Support for ISO 13485 implementation, CE marking processes and alignment with regulatory requirements.
Verification, validation and analytical testing coordination
Verification and validation engineering, coordination of in vitro tests and access to biocompatibility expertise for device qualification.
Medical device R&D consulting
Consulting across concept validation, design, prototyping and specification for medical devices.
Feasibility studies and prototyping
Feasibility assessments and preliminary prototype development to de-risk concepts before detailed design.
Design for manufacturing and industrialization planning
Development of manufacturing process specifications and industrialization strategies with certified industry partners.
Regulatory and quality system support
Support for ISO 13485 implementation, CE marking processes and alignment with regulatory requirements.
Verification, validation and analytical testing coordination
Verification and validation engineering, coordination of in vitro tests and access to biocompatibility expertise for device qualification.
Expertise Areas
- Medical device design and development
- Prototyping and feasibility evaluation
- Design for manufacturing and industrialization
- Regulatory compliance (ISO 13485, CE marking, FDA alignment)
Key Technologies
- Medical device prototyping
- Design for manufacture (DFM)
- In vitro testing methods
- Biocompatibility assessment