24. September 2020

Workshop: Introduction to Product Development and Regulatory Affairs

The goal of this workshop is to give an overview of the regulatory landscape for medical devices in Europe (MDR/IVDR) and to touch upon different aspects for USA. You will get a good understanding of the product development process, as well as the requirements regarding technical documentation. The shared insights help you to early identify the key topics of your project to be successful mid and long-term.


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22. September 2020

Are you well prepared for the new IVDR?

 

The new IVDR, coming into force on May 2022, will have major implications on your operations. The need of a notified body for app. 80% of products, even for existing ones, and the assignment of a Person Responsible for Regulatory Compliance (PRRC) are only some of them. READ MORE

Walking new paths
with Effectum Medical

We bring Medtech start-ups to market.

We support innovators in realizing their ideas, establishing sustainable businesses and to reach a successful exit. We provide an outsourced Quality Management System which our customers use to document their development, and market their Medical Devices.

Offering all needed competencies, we can act as legal manufacturer and provide our clients with a lean product registration as well as engineering services. For each project phase we offer a variety of matching services.

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.

We Care For Your Idea!

our value proposition for start-ups


Team, Network & Services

Through our team and network, we cover the entire value chain. You focus on your core competencies and we provide supply chain management as well as marketing, project management and back office services. Further more we enable direct access to financial partners and investors.

Legal Manufacturer

We can act as legal manufacturer of your product. Therefore, you do not have to go through the long process of building your own quality management system and you profit from lean product registration.


  • Reduced time to market
  • Reduced project costs
  • Risk mitigation & risk sharing
  • Higher efficiency

our value proposition for Investors


Competence

We are an experienced medtech team encompassing the necessary know-how and network of specialists to develop a successful business.

Efficiency

We are effective and efficient due to our experience and to leveraging existing organizational structures, including ISO certification.


  • Higher return on investment
  • Shorter time to exits
  • Risk hedging

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.)

We Care For Your Idea
Get In Touch

CONTACT

Effectum Medical AG
Solothurnerstrasse 235
CH-4600 Olten

+41 77 493 72 72

info [at] effectummedical [dot] com