Effectum Medical AG provides regulatory and quality‑management services for medical technology companies. Its offerings include ISO 13485‑compliant plug‑and‑play QMS, outsourced legal manufacturer services for MDR/IVDR CE‑marking, on‑demand QA/RA experts, regulatory opinions, and AI/ML compliance support.
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Industry:Pharmaceutical Industry
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Swiss-based legal manufacturer for MDR/IVDR market entry, CE marking under an existing QMS, Notified Body coordination, vigilance, post-market surveillance, PRRC services and label ownership.
Plug & Play QMS
Pre-built, cloud-based QMS for ISO 13485, MDR, IVDR and FDA compliance, with SOPs, templates, software integration, customization, training and QMS management support.
Rent an Expert
On-demand MedTech expertise for quality and regulatory affairs, software validation, audits, documentation, QMS setup, CE marking, clinical work and technical writing.
Regulatory Opinions
Written expert opinions on classification, applicable standards and approval routes for EU, CH, UK and US markets, supporting internal alignment, investor communication and MDR/IVDR/FDA planning.
AI / ML Expert
Specialized compliance support for AI- and ML-based medical devices, including MDR, IVDR and EU AI Act gap analyses, CE certification support, technical documentation and lifecycle monitoring.