Cryptych Pty, Ltd.
Provides medical device development support through a quality management–driven process, covering project management, design and engineering, prototyping, manufacturing planning, clinical research and regulatory compliance. The organisation operates an in-house capability and partner network to support device development from concept through regulatory submission and transfer to production.
Industries
N/A
Nr. of Employees
small (1-50)
Services
Program management of device development from concept to market, including vendor coordination and stage planning.
Early-stage development assessments outlining timelines, activities and cost estimates and development of strategy to reach market.
Design and engineering support using internal teams and engaged external design houses to produce regulatory-compliant designs.
Coordination with a network of prototyping partners to produce development-phase prototypes matched to project needs.
Early manufacturing engagement, supplier audits and support for transfer to production including supplier control and documentation.
Management of clinical trial activities and CRO oversight to generate clinical evidence required for regulatory submissions.
Program management of device development from concept to market, including vendor coordination and stage planning.
Early-stage development assessments outlining timelines, activities and cost estimates and development of strategy to reach market.
Design and engineering support using internal teams and engaged external design houses to produce regulatory-compliant designs.
Coordination with a network of prototyping partners to produce development-phase prototypes matched to project needs.
Early manufacturing engagement, supplier audits and support for transfer to production including supplier control and documentation.
Management of clinical trial activities and CRO oversight to generate clinical evidence required for regulatory submissions.
Expertise Areas
- Medical device design and engineering
- Clinical trial management and clinical research
- Regulatory compliance and quality management systems
- Design transfer and manufacturing readiness
Key Technologies
- Computer-aided design (CAD)
- 3D modelling and engineering drawings
- Prototyping workflows
- Injection moulding