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.
Learn about our services: Effectum Medical Service 2024/2025
• 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.)
Swiss start-up Biospectal has introduced OptiBP™, an innovative smartphone app for blood pressure monitoring. Users can measure their blood pressure quickly and conveniently in just 30 seconds by placing their fingertip on the smartphone camera. Developed in collaboration with the Swiss innovation hub CSEM, the technology uses optical biosensing and AI algorithms and meets the strict CE EU-MDR certification standards.
Key Benefits of the App:
Background:
Hypertension affects 1.3 billion people globally and is a leading contributor to heart disease, the most common cause of death worldwide. The app aims to improve early detection and management, reducing health and economic burdens. According to WHO, targeted hypertension management programs are among the most cost-effective healthcare measures.
Technology and Development:
OptiBP is based on over 15 years of research and more than two million clinical measurements. Its accuracy has been validated globally in studies conducted in Switzerland, Belgium, and low-resource settings, with support from organizations like the Bill and Melinda Gates Foundation.
Future Plans:
Following its launch in Switzerland, Biospectal plans to expand to other European and global markets.
Founded in 2017 and headquartered in Lausanne, Biospectal aims to revolutionize blood pressure monitoring. CSEM, a key partner in the technology’s development, is a renowned innovation center focused on creating impactful technologies for society.
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.
Effectum Medical AG
Kirchgasse 11
CH-4600 Olten
+41 77 493 72 72
