21. September 2021

Paving the way for innovative medical devices – overcoming regulatory hurdles for development in academia

 

Not only a great contribution by DKF (Department of Clinical Research, University of Basel) and DBE (Department of Biomedical Engineering | University of Basel), but above all a pragmatic way how to succeed in the university sector

  •   – to quickly make innovative developments available to research
  •   – to keep the well-being of patients in mind.

 

We are honored to have been selected as a partner and to be able to assist with our quality management system and regulatory affairs expertise.

These are projects that fit Effectum Medical’s DNA – bringing medical device innovations to market efficiently and cost-effectively. Many thanks  to Prof. Philippe Claude Cattin, Robin Sandkühler, Roland John, Christiane Pauli-Magnus, Dr. Unfer-Grauwiler Sandra for the great collaboration!

We are looking forward to the first market approvals and wish the team continued success!

For all interested parties, here is the access to the whole article, page 12-16
DKForum_Ausgabe17_Online-2.pdf

 

02. September 2021

Why do we need a Swiss Authorized Representative (Swiss AR)?

Health Tech Cluster Switzerland’s event “Why do we need a Swiss Authorized Representative (Swiss AR)?” last week showed that interest remains high.

Our three Key Take Aways:

  • The swissmedic sheet clearly lays out the two fundamental levels: Physical product responsibility – manufacturer, importer, distributor; Formal and safety concerns – CH REP.
  • The role of the importer is significantly enhanced in the logistics chain, as he ensures that only products that comply with the MepV are placed on the market.
  • Contrary to all expectations, swissmedic does not specify the location of the “Person Responsible for Regulatory Compliance”. The decisive factor is that he or she is able to exercise the responsibility in accordance with the legal requirements

Many thanks again to Stefan Leuthold for inviting Ulrike Neuberger. It was a pleasure to organize the event together with Beni Hirt and Michael Maier!

If you have any further questions, please feel free to contact us!

 

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.)

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.

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