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DirectoryIndustryPharmaceutical IndustryOltenEffectum Medical AG
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Effectum Medical AG

Summary

About the company

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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Offering

Products & services

Industry:Pharmaceutical Industry
✓ Offered
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5
Outsourced Legal Manufacturer
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.
Press

Media

March 17, 2025Media
Healthcare Holding Schweiz erwirbt Effectum CH-Rep
leaderdigital.ch

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Location

Kirchgasse 11
4600 Olten
Opening hours
Mon
09:00 - 17:00
Tue
09:00 - 17:00
Wed
09:00 - 17:00
Thu
09:00 - 17:00
Fri
09:00 - 17:00
Sat
Closed
Sun
Closed

At a glance

Legal form
Corporation
UID
CHE-389.095.825
Founded
2017 · 9 years
Last commercial register change
March 27, 2026
Employees
11 to 20

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