Epmodex
Consulting and engineering firm focused on development, certification and market introduction of medical and industrial products. Services include product design and development, regulatory strategy and authorization (MDR/MDD/MedDO), systems engineering and industrialization support, quality management (ISO 13485) and Swiss market representation.
Industries
Nr. of Employees
small (1-50)
Products
Plass rescue occluder — prototype and proof-of-concept development
Proof-of-concept and functional prototype development for a wound occlusion device intended to prevent haemorrhage; included verification prototypes and iteration based on handling requirements.
Technical remediation and documentation support (case study)
Remediation program for technical and risk-management documentation to achieve MDR compliance for an established medical device manufacturer.
Plass rescue occluder — prototype and proof-of-concept development
Proof-of-concept and functional prototype development for a wound occlusion device intended to prevent haemorrhage; included verification prototypes and iteration based on handling requirements.
Technical remediation and documentation support (case study)
Remediation program for technical and risk-management documentation to achieve MDR compliance for an established medical device manufacturer.
Services
Product design & development
Engineering and development services to convert concepts or existing designs into market-ready medical products, including documentation and quality engineering.
Product authorization & regulatory consulting
Regulatory strategy, gap analysis, technical documentation updates, notified body application support and MDR compliance programs.
System realization and industrialization
Modular services for system realization of complex products, industrialization, change management and transfer to production under ISO 9001 / ISO 13485 frameworks.
Swiss Authorized Representative & importer services
Swiss AR designation, liaison with Swissmedic, maintenance of documentation, incident reporting and assistance in gaining Swiss market access.
Product design & development
Engineering and development services to convert concepts or existing designs into market-ready medical products, including documentation and quality engineering.
Product authorization & regulatory consulting
Regulatory strategy, gap analysis, technical documentation updates, notified body application support and MDR compliance programs.
System realization and industrialization
Modular services for system realization of complex products, industrialization, change management and transfer to production under ISO 9001 / ISO 13485 frameworks.
Swiss Authorized Representative & importer services
Swiss AR designation, liaison with Swissmedic, maintenance of documentation, incident reporting and assistance in gaining Swiss market access.
Expertise Areas
- Medical device design and development
- Regulatory compliance (MDR / MedDO / MDD)
- Quality management (ISO 13485) implementation
- Systems engineering for safety-critical products
Key Technologies
- Systems engineering
- 3D metrology (CMM & CT scanning)
- Design verification and validation
- UDI systems and EUDAMED reporting