Archimedic
Archimedic is a focused team of medical device developers dedicated to transforming medtech visions into market realities through design, regulatory, and go-to-market services. They emphasize innovation, compliance, and strategic planning to help clients succeed in the medical device industry.
Industries
Nr. of Employees
small (1-50)
Products
Open-source QMS templates and training
Collection of QMS templates and instructional materials for design, regulatory, and go-to-market processes including design inputs, traceability matrices, risk forms, FMEA, and pre-submission templates.
Drug-delivery platform (ampoule-based)
Development-stage ampoule-based drug-delivery platform designed to address drug stability and usability considerations for injectable, transdermal, and topical administrations.
Selected case-study device projects
Documented examples of multidisciplinary device projects across respiratory therapy, surgical tools, diagnostics, wearables, and wound detection demonstrating concept-to-manufacturable design work.
Published guidance and thought-leadership articles
Collection of articles and guides on clinical strategy, regulatory planning, supply chain development, fundraising diligence, and value analysis intended to inform medtech development decisions.
Open-source QMS templates and training
Collection of QMS templates and instructional materials for design, regulatory, and go-to-market processes including design inputs, traceability matrices, risk forms, FMEA, and pre-submission templates.
Drug-delivery platform (ampoule-based)
Development-stage ampoule-based drug-delivery platform designed to address drug stability and usability considerations for injectable, transdermal, and topical administrations.
Selected case-study device projects
Documented examples of multidisciplinary device projects across respiratory therapy, surgical tools, diagnostics, wearables, and wound detection demonstrating concept-to-manufacturable design work.
Published guidance and thought-leadership articles
Collection of articles and guides on clinical strategy, regulatory planning, supply chain development, fundraising diligence, and value analysis intended to inform medtech development decisions.
Services
Industrial and product design covering concept exploration, electromechanical packaging, aesthetic development, and design-for-manufacturability.
Regulatory pathway definition, predicate/reference analysis, preparation of pre-submission materials, and submission support tied to targeted test plans.
Formative and summative human factors studies including protocol drafting, recruitment, test execution, and reporting to support usability validation and regulatory evidence.
Targeted prototype programs using functional rigs, mockups, and iterative builds to isolate technical or usability risks and produce actionable test data.
Implementation and management of medical device QMS practices including document control, CAPA workflows, and template provisioning aligned to ISO 13485.
Test protocol development, test execution, simulation, data collection, and reporting spanning feasibility, EVT, and full V&V campaigns.
Industrial and product design covering concept exploration, electromechanical packaging, aesthetic development, and design-for-manufacturability.
Regulatory pathway definition, predicate/reference analysis, preparation of pre-submission materials, and submission support tied to targeted test plans.
Formative and summative human factors studies including protocol drafting, recruitment, test execution, and reporting to support usability validation and regulatory evidence.
Targeted prototype programs using functional rigs, mockups, and iterative builds to isolate technical or usability risks and produce actionable test data.
Implementation and management of medical device QMS practices including document control, CAPA workflows, and template provisioning aligned to ISO 13485.
Test protocol development, test execution, simulation, data collection, and reporting spanning feasibility, EVT, and full V&V campaigns.
Expertise Areas
- Medical device industrial design
- Human factors and usability engineering
- Clinical study planning and outcomes definition
- Regulatory strategy and pre-submission planning
Key Technologies
- CAD/CAM
- Rapid prototyping (3D printing, laser cutting)
- Injection molding and tooling
- PCB design and embedded systems
News & Updates
Insights into overcoming challenges in medtech fundraising.
Understanding the angel investor due diligence process in medtech.
Exploring the intersection of design and value analysis in medical devices.
Strategies for building efficient supply chains in medtech.
Key checks to ensure readiness before design freeze in medtech.
Insights into overcoming challenges in medtech fundraising.
Understanding the angel investor due diligence process in medtech.
Exploring the intersection of design and value analysis in medical devices.
Strategies for building efficient supply chains in medtech.
Key checks to ensure readiness before design freeze in medtech.