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

Our Plug-and-play QMS

• 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

➡️ Effectum-Medical-Service-2024_2025 ⬅️

Outsourced Legal Manufacturer

• 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

When you Choose Us
What Makes Us Different?

We maintain a quality management system according to ISO standards for medical devices.

We share the risk by acting as legal manufacturer for your product.

We support you in maintaining your product registration (i.e. process validations, post market surveillance, etc.).

We offer organizational structure & back office services, enabling you to focus on your core business.

We offer a wide range of services and infrastructure
you choose what you need

Team
.

Interdisciplinary core-team with competence and experience in

ISO Certification
Product development
Product registration
Marketing
Business development

Infrastructure
.

Encompassing infrastructure & services

Quality Management System (ISO)
Legal Manufacturer
Central back office services

Network
.

Extensive network of partners and experts

Suppliers & manufacturers
Surgeons of different specialties
Scientific & technical experts
Financing partners

Project
Management

Profound project management skills in

Project coaching
Set-up & planning of projects
Project management
Processes
Systems (profit center, QMS, PLM, contracts, etc.)

Our Core Values

Innovative

The DNA of Effectum Medical is an innovative business model. It is therefore only natural that we are always on the lookout for new solutions for our partners and customers to jointly pursue future-oriented paths.

Efficient

Lean structures and a clear understanding of our customers’ needs and the crucial elements in the product approval process, allow us to work in a solution-focused and target driven manner.

Strong in
implementation

We do not see ourselves as theorists. We want to successfully bring our customers' ideas to market. Conceptual thinking combined with pragmatism makes us a strong partner who knows what really matters.

Agile

We understand the requirements of an agile product development and live this approach for our customers. A clear customer focus and high-quality service are very important to us.

Competent

We are reliable partners in the fields of quality management, regulatory affairs, and project management, who possess not only specialized knowledge but also a wealth of operational experience along the entire value chain - from idea to global roll-out.

Respectful

Respect and recognition are an important basis for a successful collaboration. A partnership of equals is what we strive for - with our customers, suppliers and as a team.

10. February 2025

New report alert: Unlock the €498bn German healthcare market

We had the opportunity to review the latest report from EIT Health, and we’re proud to have contributed to this important work. Thank you to EIT Health for trusting us with this task. It’s been great to support such a valuable initiative that drives innovation and progress in healthcare across Europe.

EIT Health is proud to launch “MedTech and Digital Health: A Comprehensive Guide to Market Access in Germany”. This essential guide offers European healthcare start-ups actionable insights to navigate Germany’s complex regulatory landscape and seize opportunities in Europe’s largest healthcare market.

What’s inside?
Tips for regulatory success, including MDR & CE certification.
A guide to Germany’s reimbursement pathways (DiGA, SHI, PHI).
Proven market entry strategies, drawn from real-world success stories.

Whether you’re just starting out or planning to expand, this guide equips you to unlock Europe’s largest healthcare market.

Download it now and accelerate your market entry: https://loom.ly/Nse1-fM

Stay tuned for more reports to empower your MedTech and digital health journey across Europe.

14. January 2025

New opportunity – Medical Device Expert Software 80 -100%

We are currently looking for a

Medical Device Expert Software (80-100%)

to join our team.

In this position you

Your primary focus will be on projects involving medical software and active medical devices/IVDs with embedded software across all risk classes.
You will collaborate with customers, ranging from start-ups to teams within global corporations, to refine their technical documentation to meet the requirements for CE marking or FDA approval.
Your responsibilities will include reviewing, approving, and contributing to the establishment of technical documentation. READ MORE

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Our Plug-and-play QMS

Outsourced Legal Manufacturer

When you Choose Us
What Makes Us Different?