Artificial intelligence (AI), and specifically machine learning (ML), has become an important part of an increasing number of medical devices. Due to the increased interest in these medical devices, the FDA has basis a publicly available information created a list of AI/ML-enabled medical devices currently being marketed in the US.
The list is not an exhaustive or comprehensive resource of AI/ML-enabled medical devices but gives an overview of what is currently available.
We feel honoured that Verve Ventures has interviewed Karina to receive insights about market access and regulatory. Read the full interview here.
We support innovators in realizing their ideas, establishing sustainable businesses and to reach a successful exit. We provide an outsourced Quality Management System which our customers use to document their development, and market their Medical Devices.
Offering all needed competencies, we can act as legal manufacturer and provide our clients with a lean product registration as well as engineering services. For each project phase we offer a variety of matching services.
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.
We Care For Your Idea!
Through our team and network, we cover the entire value chain. You focus on your core competencies and we provide supply chain management as well as marketing, project management and back office services. Further more we enable direct access to financial partners and investors.
We can act as legal manufacturer of your product. Therefore, you do not have to go through the long process of building your own quality management system and you profit from lean product registration.
We are an experienced medtech team encompassing the necessary know-how and network of specialists to develop a successful business.
We are effective and efficient due to our experience and to leveraging existing organizational structures, including ISO certification.
#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.)
Effectum Medical AG
Kirchgasse 11
CH-4600 Olten
+41 77 493 72 72
