Healthcare innovation is in the heart of our co-founders’ DNA and our vision is to bridge the gap between idea and implementation by offering an Plug-and-Play quality management system (QMS) and acting as legal manufacturer.
The Effectum Medical team unites hands-on MedTech business and management experience with in-depth knowledge of regulatory affairs and quality management for medical devices, medical software and in-vitro diagnostic products. In addition, we provide access to a unique network of experts along the entire value chain.
Not only Startups, but also R&D, Regulatory Affairs and Quality Management teams of established MedTech Companies can count on us as an external service provider.
Through Effectum CH-REP, a company of Effectum Medical, we give companies domiciled outside of Switzerland access to the Swiss market by acting as their Swiss Authorized representative.
• is compliant with ISO 13485, MDD/MDR, IVDD/ IVDR and FDA standards
• covers more than 40 norms
• has a modular concept with 30 Standard Operating Procedures (SOP’s) and 150 templates
• is enriched with individual service packages
• has withstood 9 Notified Body audits in the last five years
• A QMS applied daily for medical devices, medical software and IVD products
• A QMS continuously enhanced to ensure optimal workflows
• A QMS regularly audited by notified bodies and customers
• Through our QMS 8 products have been successfully certified and more than 10 are in the pipeline
• We actively apply the same framework for our legal manufacturer services
• are responsible for Post Market Surveillance, Vigilance & Complaint Handling
• take care of supplier validation and audits
• handle the operations part from production until delivery to warehouse
• keep all documentation needed to maintain product certification up to date
• Focus on innovation, product development and technical documentation
• Shorten time to market by splitting roles and responsibilities
• Avoid wasting resources on non-core activities, e.g. preparation and realization of audits
• Overcome the current shortage of Notified Bodies
We maintain a quality management system according to ISO standards for medical devices.
We share the risk by acting as legal manufacturer for your product.
We support you in maintaining your product registration (i.e. process validations, post market surveillance, etc.).
We offer organizational structure & back office services, enabling you to focus on your core business.
Quality Management System (ISO)
Central back office services
Suppliers & manufacturers
Surgeons of different specialties
Scientific & technical experts
Set-up & planning of projects
Systems (profit center, QMS, PLM, contracts, etc.)
Accelerate your innovation journey: A (public) funding guide for Swiss start-ups.
In a joint session with Noemí Quesad, Business Development Manager at Evolution Europe, a guide to public funding for Swiss start-ups will be presented. Learn how to accelerate your innovation journey and gain insights into the funding opportunities available for Swiss start-. Join us to gain valuable information and take your start-up to the next level.
📅 March 11, 2024
🌐 Online event
Register now for the free lunchtime event and gain insights into financing opportunities for Swiss start-ups.
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Effectum Medical AG
+41 77 493 72 72