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)
Products
Cryptych Medical Device Support and Development Solution
A comprehensive medical device development solution offering streamlined pathways to market, regulatory support, and a compliant Quality Management System.
Regulatory Compliance
Achieving route-to-market compliance through certified Quality Management Systems and collaboration with appointed partners.
Design & Engineering
Experienced designers and engineers execute project design, ensuring products meet regulatory and market requirements.
Assessment & Strategy
Early-stage overview of the development path, timelines, activities, and likely expenses, supported by strategy development.
Prototyping
Access to a network of prototyping partners matched to specific phases of product development.
Manufacture
Early engagement of manufacturing facilities to streamline the process, ensure compliance, and manage technology transfer.
Cryptych Medical Device Support and Development Solution
A comprehensive medical device development solution offering streamlined pathways to market, regulatory support, and a compliant Quality Management System.
Regulatory Compliance
Achieving route-to-market compliance through certified Quality Management Systems and collaboration with appointed partners.
Design & Engineering
Experienced designers and engineers execute project design, ensuring products meet regulatory and market requirements.
Assessment & Strategy
Early-stage overview of the development path, timelines, activities, and likely expenses, supported by strategy development.
Prototyping
Access to a network of prototyping partners matched to specific phases of product development.
Manufacture
Early engagement of manufacturing facilities to streamline the process, ensure compliance, and manage technology transfer.
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