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.
06. May 2024

Next Plug & Play Bootcamp – Autumn 2024

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

 

 

 

 

05. March 2024

Discover our two podcast episodes with Karina and Nila!

In the first podcast interview with Karina Candrian, you will find out how an impressive company growth of 400% was possible in just a few years. Also find out how our ‘Priority Board’ helps to manage internal processes and how we establish and maintain our company culture.

Spotify: https://lnkd.in/e2CxRMuw
Apple: https://lnkd.in/gXFE2CDF
Google: https://lnkd.in/gp7cRhSi


In the second podcast with Nila-Pia Rähle, it’s all about the ‘healthcare marketplace’. Nila shares insights on how she supports start-ups in getting their products approved and shows ways to bring them to market faster.

Website: www.gesundheitswesen.org
Spotify: https://lnkd.in/etEWtdPi
Apple Podcasts: https://lnkd.in/eHdd6ryF
Soundcloud: https://lnkd.in/eUUDrk6R

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