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.)
We believe the secret to enjoy work is also to have fun and laugh as a team. Some of statements we liked most in 2022!
Markus Tanner is our new Senior Quality Manager and he joined us in January. Markus brings more than 14 years’ experience from mainly Complaint Handling, Vigilance Reporting, CAPA, HHE, Field Action, Audits, Risk Management and Quality Management Systems (CFR 21 part 820, ISO13485, ISO14971 and MDR).
Markus who is Swiss, lives with his family close to the beautiful Lake Constance. He enjoys family time, sports (skiing & jogging) and reading. Markus is a keen fisherman, but he has realized that instead of improving, the output keeps getting worse by each year.
It’s great to have you on board!
Effectum Medical AG
Kirchgasse 11
CH-4600 Olten
+41 77 493 72 72
