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 outsourced 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 workfl ows

•  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.
03. October 2022

Effectum Medical a supporter of the Swiss healthcare ecosystem

Swiss Healthcare Startups is a non-profit organisation that supports innovative startups that aim to add value to the Swiss healthcare ecosystem. The organisation supports startups by providing meaningful exposure and facilitating access to relevant stakeholders thanks to an exclusive digital directory, an extensive partner network, and by organising some of the most inspiring events in Swiss healthcare.

Healthcare innovation is at the heart of Effectums’s business and as an institutional member of Swiss Healthcare Startups we look forward to supporting the Swiss Healthcare ecosystem.

29. August 2022

ISO 13485 Certificate for In-Vitro Diagnostic products received

In spring, we completed our first IVD audit and our ISO 13485 certificate for In-Vitro Diagnostic products has now arrived! This has been the next important step for us to complete our service offering which now covers In-Vitro diagnostics in addition to Medical Device products and software. We are of course pleased to have received the certificate, but we are equally happy to have team members with a proven track record in diagnostics who can expertly accompany our customer projects.

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