we build medtech & ivd companies...jun 05, 2018 · « testimonials » 01.06.18 effectum...

«We build Medtech & IVD Companies »

Karina Candrian Schaffhausen, June 5, 2018

«Innovators in Medtech are having a hard time bringing new products and services to market. - That’s what we change. »

med

tech

experience regulatory pathway

time

to m

arke

t

product development

business model

business

financing entrepreneurship

start-up quality management

product registration

suppliers

manufacturing

reimbursement

innovation

project management

ideas

engineering capital

administration

technology network planning

marketing

ISO Certification

best practice

strategy

risk

01.06.18 2 Effectum Medical AG – Company Presentation

planning

« We accelerate time to market by giving our customers access to our QMS and acting as legal manufacturer »

01.06.18 Effectum Medical AG – Company Presentation 3

time

Setup operation

QA/RA staff

QMS / company certification

Technical File / Product Certification

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lf Q

A/R

A co

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Effe

ctum

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edic

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ISO CE

time

time

cost

. . QMS / company certification

Technical File / Product Certification

. . . Technical File / Product Certification

ISO CE

CE You start here

« Effectum Medical as Legal Manufacturer »


Advantages Disadvantages

•  Effectum Medical appears as legal manufacturer on the label (nevertheless own branding possible)

•  You have more time to focus on value creating activities, such as product develompent, launch preparations, market development, marketing, and sales.

•  You do not have to worry about changing norms, regulations, and deadlines.

•  You do not need an own ISO certification. •  Your profit from lower costs for quality

assurance as you can share them with other companies.

•  You profit from faster product certification (good, existing relation/collaboration with our notified body).

« Services of Effectum Medical »


ISO Certification Product Certification

•  Upon request, preparation of or support with technical file for product certification

•  Maintenance of product certification: •  Validations •  Post Market Surveillance •  Change notifications •  Supplier audits •  Up-date of technical file

•  Payment of all costs and fees for product certification

•  Liability as legal manufacturer

•  Re-registration according to MDR/IVDR

•  Maintenance of quality management system according to ISO standards for medical devices

•  Annual ISO audits (incl. Preparation and debriefing)

•  Elimination of all non-conformities from ISO audits

•  Monitoring of norms and regulations, and adaptation of QM system

•  Payment of all costs and fees for ISO audits

•  Transfer from MDD to MDR/IVDR

« Our Team Members: A interdisciplinary team with a broad range of competencies and many years of experience in medtech »


Karina Candrian CEO

Nila-Pia Rähle COO

Jens Richter CTO

Rolf Schmid CFO/CMO

Founders & management team

Ulrike Neuberger Medical Devices

Dr. Daniel Caminada Diagnostics

Dr. Kurt Ruffieux Dental

Reto Schöni QM & RA

Team

Advisory Board

Dr. Michael Ahrens Prof. Dr. Philippe Cattin Dr. Heiko Visarius Beat Steffen

01.06.18 Effectum Medical AG – Company Presentation

7

« Our Strategic Business Partners »

Financial Partners Execution Partners

Start-up One-stop-shop Risk mitigation Testing of MVP

SME

Focus on distribution &

marketing Risk mitigation

Pharma-ceutical

company

Focus of clinical affairs team on core business

Global player

«fast track development» execution partner

Enginee-ring

company

Complementary skills Collaborative project ownership

« Different Customer Profiles – different reasons for working with Effectum Medical »


8

Two reasons for working with Effectum are the same for all customers profiles: saving time and saving costs

« Collaboration example - The centre piece was missing »


9

IGNITE-concepts with Focus •  Innovation •  Consulting •  Proof of Concept •  Engineering •  CAD services •  IP creation •  19 yrs Medtech

experience

(Bio)mechanical testing

Production according to ISO 13485

KOL Surgeon network

Financing

Medtech Network

Patent council

Cadaveric testing


EP (B1) JP (B2) CN (B) KR (B1) US (A1) IN (A1) TW (A1)

80 kN

Project example: High tibial osteotomy

« Testimonials »


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Potential exit partners of a start-up do not want to buy costly quality and regulatory processes as they have their own. Outsourcing to Effectum Medical allows me to invest more into technology, product and IP, creating a higher return on investment. (Dr. Kurt Ruffieux, Chromeopharm, customer of Effectum Medical)

Effectum Medical offers complementary skills to mine, offers start-up friendly tailored solutions, and is sharing the driver-seat with me. (Tom Overes, Ignite Concepts, Customer of Effectum Medical)

Effectum Medical is a one-stop-shop for inventors and start-up founders of medical devices and puts the timeline on a fast track for a product from idea to market. (Dr. Michael Ahrens, Advisory Board Member)

Effectum Medical makes a key difference for start-ups and small companies regarding time to market and eliminates the hassle of finding a suitable Notified Body. (Beat Steffen, Advisory Board Member)

« What makes us different? »

You focus on your idea and core competencies - We build the company together.

We maintain a quality management system according to ISO standards for medical devices and IVD.

We share the risk by acting as legal manufacturer for your product.

We support you in maintaining your product registration (i.e. process validations, post market surveillance, etc.).

We offer organizational structure & back office services, as well as access to project financing.


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Effectum Medical AG Ringstrasse 28 CH-4600 Olten [email protected] effectummedical.com

Thanks for your interest! Please contact us, we are looking forward to a fruitful collaboration!

we build medtech & ivd companies...jun 05, 2018 · « testimonials » 01.06.18 effectum...

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