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 a Plug-and-Play quality management system (QMS) and acting as legal manufacturer of medical devices (including IVDs).
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.
Learn about our services: Effectum Medical Services
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• is compliant with ISO 13485, MDD/MDR, IVDD/ IVDR and FDA standards
• is audited on a regular basis by customers and notified bodies
• is continuously improved to comply with regulatory updates and other improvements
• is freely configurable to your own needs and QMS scope
• Several companies (including ourselves) have passed notified body audits using the proposed QMS package
• We can provide support and training in the configuration or management of your QMS
• The QMS processes are easily understandable and clear.
• are responsible for Post Market Surveillance, Vigilance & Complaint Handling
• take care of supplier validation and audits
• Review and co-create the required documentation to facilitate compliance and obtain product (self-)certification
• keep all documentation needed to maintain product certification up to date
• Focus on innovation, product development and technical documentation
• Overcome the current shortage of Notified Bodies
• Retain full ownership of your intellectual property (IP) while benefiting from a streamlined path to market
• The QMS maintenance costs are shared between several companies – making outsourced LM a cost-effective solution
• Fast track certification solution by using (if possible) our notified body Technical Documentation sampling process
➡️ The Benefits of Outsourced Legal Manufacturing with Effectum Medical ⬅️
#1
We maintain a quality management system according to ISO standards for medical devices.
#2
We share the risk by acting as legal manufacturer for your product.
#3
We support you in maintaining your product registration (i.e. process validations, post market surveillance, etc.).
#4
We offer organizational structure & back office services, enabling you to focus on your core business.
ISO Certification
Product development
Product registration
Quality Management System (ISO)
Legal Manufacturer
Suppliers & manufacturers
Surgeons of different specialties
Scientific & technical experts
Project coaching
Set-up & planning of projects
Project management
Processes
Systems (profit center, QMS, PLM, contracts, etc.)
Effectum Medical beschreitet neue Wege in den Bereichen Qualitätsmanagement und Regulatory Affairs in der MedTechBranche. Unsere Vision ist es, einen effizienten, beschleunigten Marktzugang für innovative Medizinprodukte zu ermöglichen. Mit unserem Plug-and-Play-QMS und unseren Legal Manufacturing Lösungen streben wir danach, immer die branchenweit modernste Lösung zu bieten.
Unsere Kunden sind sowohl Start-ups und KMUs als auch weltweit operierende Unternehmen. Konzeptionelles Denken kombiniert mit Pragmatismus machen uns zu einem starken Partner, der weiß, worauf es wirklich ankommt.
Zur Ergänzung unseres Teams suchen wir per sofort oder nach Vereinbarung eine/n
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MedTech startups often face complex regulatory hurdles and high costs. Our new White Paper reveals how outsourcing Legal Manufacturing to Effectum Medical helps overcome these challenges: Faster market entry, reduced costs, and lower risks – all while maintaining full control over your intellectual property.
Discover how partnering with a certified expert can bring your innovation to market efficiently.
Download now and gain a competitive edge!
The Benefits of Outsourced Legal Manufacturing with Effectum Medical
Effectum Medical AG
Kirchgasse 11
CH-4600 Olten
+41 77 493 72 72