MYRA Medical Sàrl is a medtech development and consulting company that supports the design and regulatory approval of transcatheter interventional devices for cardiovascular and oncology applications. Services include R&D and design, prototype manufacturing (including an ISO 7 clean room), regulatory and clinical program planning, project management, patent strategy, due diligence and fundraising support for startups.
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Industry:Medical Technology Industry
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Design of active and passive medical devices, including implantable products; feasibility analysis, initial prototypes, FEA, and support with an ISO 7 cleanroom for the preclinical and clinical phases.
Regulatory and Clinical Programs
Regulatory development plans, test plans, technical dossiers, CE and FDA approvals, as well as clinical plans including protocol, budgeting, execution, data analysis and reporting.
Virtual Startup Incubator
Providing embedded engineering resources for startups, supporting R&D through prototyping, technical coaching and help with building staff and continuity.
Project Management - Business Plans and P&L
Project management for MedTech developments with scheduling, cost monitoring, and preparation of business plans and profit-and-loss statements for investor meetings.
Due Diligence
Due-diligence support for biomedical projects focusing on regulatory pathways, R&D, technical feasibility, clinical data, IP landscape and competitive environment.
Patents
Support with patent filing strategies, drafting patent applications and drawings, and preliminary freedom-to-operate analyses for medical technology projects.
Fund Raising
Support with technical, business and financial presentations, accompanying investor meetings and information services to identify suitable investors.
Project Financial Management
Daily financial management of development projects with cost control, expense models, supplier procurement, expense and cash-flow monitoring.
Talent Development
Training and talent development program for medical device development in Mechanical and Biomedical Engineering, Biology and Chemistry, and Pharmaceutical Technologies.
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