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
#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 are delighted to have been listed as one of the 9 top medical device consulting firms of 2024. You can find the article here
Contact us to learn more about Effectum’s activities and how we can support you as legal manufacturer of your product, as consultants or in setting up your own QMS with our SOP packages.
We are happy to announce the completion of our second QMS Bootcamp with excellent participants and discussions! Thank you and well done to all!
The buzz surrounding our next Bootcamp this Autumn is growing. Now is the perfect time to seize this opportunity and equip yourself and your team with the knowledge and skills needed to navigate the complexities of quality assurance in combination with our proven Plug&Play SOP Packages.
Whether you’re a seasoned professional or new to the field, our Bootcamp offers a comprehensive learning experience tailored to meet the demands of today’s regulatory environment. The bootcamp helps all companies wishing to setup their own Quality Management System and gives you a kick-start when it comes to implementing and configuring the processes to your needs.
Join us this Autumn for our next Plug & Play QMS Bootcamp and take the next step toward ensuring a compliant QMS and the safety
All dates and more information can be found here: 2024-Autumn_Plug-Play-Bootcamp-Effectum-Medical_V1.pdf
Effectum Medical AG
Kirchgasse 11
CH-4600 Olten
+41 77 493 72 72
