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 outsourced 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 workfl ows
• 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
#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
Marketing
Business development
Quality Management System (ISO)
Legal Manufacturer
Central back office services
Suppliers & manufacturers
Surgeons of different specialties
Scientific & technical experts
Financing partners
Project coaching
Set-up & planning of projects
Project management
Processes
Systems (profit center, QMS, PLM, contracts, etc.)
Swiss Healthcare Startups is a non-profit organisation that supports innovative startups that aim to add value to the Swiss healthcare ecosystem. The organisation supports startups by providing meaningful exposure and facilitating access to relevant stakeholders thanks to an exclusive digital directory, an extensive partner network, and by organising some of the most inspiring events in Swiss healthcare.
Healthcare innovation is at the heart of Effectums’s business and as an institutional member of Swiss Healthcare Startups we look forward to supporting the Swiss Healthcare ecosystem.
In spring, we completed our first IVD audit and our ISO 13485 certificate for In-Vitro Diagnostic products has now arrived! This has been the next important step for us to complete our service offering which now covers In-Vitro diagnostics in addition to Medical Device products and software. We are of course pleased to have received the certificate, but we are equally happy to have team members with a proven track record in diagnostics who can expertly accompany our customer projects.
Effectum Medical AG
Kirchgasse 11
CH-4600 Olten
+41 77 493 72 72
