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.

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


➡️ Plug & Play QMS Service Overview⬅️

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?

#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.

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

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.
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.
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.
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.
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.
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.
19. February 2024

Joint lunch session with Evolution Europe

Accelerate your innovation journey: A (public) funding guide for Swiss start-ups.

In a joint session with Noemí Quesad, Business Development Manager at Evolution Europe, a guide to public funding for Swiss start-ups will be presented. Learn how to accelerate your innovation journey and gain insights into the funding opportunities available for Swiss start-. Join us to gain valuable information and take your start-up to the next level.

📅 March 11, 2024
⏱️ 12-13h
🌐 Online event

Register now for the free lunchtime event and gain insights into financing opportunities for Swiss start-ups.

 

 

19. February 2024

New opportunity – Project Manager Supply Chain 80-100%

We are currently looking for a

Project Manager Supply Chain (80-100%) 

to join our team.

In this position you

  • work at the interface of our customers, suppliers, and internal team members
  • are part of the project management team for our legal manufacturing services and you take over work packages in the area of supply chain set-up and management
  • will be responsible for managing the supplier files within our eQMS and within the product specific technical documentation folders.
  • liaise with suppliers and customers to obtain supplier relevant information such as copies of the supplier’s current certification, material data sheets and much more
  • are responsible for the operational procurement process of assigned products, including release and tracking of purchase orders and preparation of documentation for import/export together with logistics partners READ MORE

We Care For Your Idea
Get In Touch

CONTACT

Effectum Medical AG
Kirchgasse 11
CH-4600 Olten

+41 77 493 72 72

info [at] effectummedical [dot] com