Services SWISS AUTHORIZED REPRESENTATIVE (CH-REP)

EFFECTUM MEDICAL supports 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.

#0

Kick-off

pre-project phase

Regulatory Opinion

Project Phase	#0 Pre-Project
Service	Review of “intended use” Review of classification according to MDR/IVDR Identification of applicable regulations, classification, conformity assessment procedure Sketching of possible regulatory pathways
Benefits	Independent and objective opinion on classification of product Insights and recommendation on possible regulatory pathways Insights on open questions and clarification No obligations to partner with Effectum Medical

Basic training on QMS

Project Phase	#0 Pre-Project
Service	Training on Effectum Medical Quality Management System Kick-off training to start working on the project Training on the next project phase after respective review meeting
Benefits	Immediately ready to work on relevant documents Continuity on the project Benefit from MedTech /IVD experts’ knowledge and experience

Workshop / Training Sessions

Project Phase	#0 Pre-Project
Service	Workshop/ training sessions on various topics for management and team members of start-ups, spin-offs, fellows Learning from practical examples and case studies Workshop/ training sessions can be customized to our customers needs
Benefits	Opportunity to bring a new spirit into the team and initiate valuable reflections Encouraging to rethink and sharpen ideas and approaches Benefit from MedTech/ IVD start-up experts’ knowledge and experience

Project Management

Project Phase	#1 – #5 Troughout the entire project
Service	Set-up and planning of projects Project management Application of efficient and proven processes Access to established systems like profit center, QMS, PLM, contracts, etc. Coaching and advice on project planning and project management
Benefits	Professional project management based on profound skills and expertise in MedTech/ IVD projects Reliable and lean project plan and budget based on experience from comparable projects More time to focus on core competencies and value creating activities

Training & coaching

#1

Design
Input
Requirements

Design & Development

Engineering

Project Phase	#1 Design & Development
Service	Engineering of implants and instruments for all anatomical regions Creative technical problem solving Design optimization for lean and cost saving production Design optimization for user friendly OR-handling, cleaning and sterilization Aesthetic design optimization by industrial design engineering
Benefits	Technical realization of product ideas from prototypes up to final products to use in the OR Technical solutions for clinical challenges Optimization of existing design for better handling, cost saving production, better cleanability

Technical Documentation
Independent reviewer
Supplier evaluation & selection

Project Management

Project Phase
Service
Benefits

Access to EM-QMS – for incubators

Project Phase	#1 – #2 Design & Development
Service	Access to SOP “Design and Development” and dedicated documents to complete phase 1 for design and development planning and phase 2 for design freeze Training and coaching on QM, documentation and/ or preparation of technical file Preparation and conduct of review meetings
Benefits	Professional ISO 13485 and FDA compliant framework for documentation of product development Experts training and coaching on documentation according to ISO 13485 and FDA Increased attractivity for innovators/ students compared to competition Increased out-put by shortening time to market for spin-offs Gain visibility by offering innovative «market access» solution No need to hire staff with expertise in QM/RA

Access to EM-QMS – All-in

Project Phase	#1 – #5 Design & Development, Industrialization, product launch / post-market phase
Service	Access to Quality Management System for development and distribution of medical devices, invitro diagnostics and medical software Upgrade of QMS from MDD/IVDD to MDR/IVDR Training on QMS and coaching on documentation and/or preparation of technical file
Benefits	«plug-and-play»; immediate access to relevant documents Save time and money by using an established QMS with notified body Professional ISO 13485 and FDA compliant framework for documentation of product development Experts training and coaching on documentation according to ISO 13485 and FDA More time to focus on core competencies and value creating activities

Shared norms & standards

Project Phase	#1 – #5 Design & Development, Industrialization, product launch / post-market phase
Service	Access to all relevant standards for medical devices, invitro diagnostics and medical software
Benefits	Save time and money by using an existing set of standards

Training & coaching

#2

Design
Freeze

#3

Design
Transfer

Industrialization

Shared re-processing validation

Project Phase	#3 Industrialization
Service	“Worst-case instruments” reprocessing validation as a basis for approval of new instruments Reprocessing instructions (cleaning, disinfection and sterilization) Reprocessing validation summary report
Benefits	Save time by using existing validation Save money through sharing validation with others

Supplier audits
Supplier management
Verification & Validation

Project Management

Project Phase
Service
Benefits

Access to EM-QMS – All-in

Project Phase
Service
Benefits

Shared norms & standards

Project Phase
Service
Benefits

Training & coaching

#4

Verification &
Validation

#5

Declaration of Conformity

product launch / post-market phase

Legal Manufacturer

Project Phase	#5 Product Launch / Post-Market Phase
Service	Effectum Medical acts as legal manufacturer for customer branded and distributed products Support and maintenance of technical file Maintenance of product certification (validation, post market surveillance, technical file, etc.) Liability at Effectum Medical as legal manufacturer Re-registration according to MDR/IVDR
Benefits	More time to focus on value creating activities No worrying about changing standards and regulations No need for own ISO certification Lower costs for quality assurance as you can share them with other companies Faster product certification thanks to established collaboration with our notified body Release from product liability

Post Market Surveillance
Product management

Project Management

Project Phase
Service
Benefits

Access to EM-QMS – All-in

Project Phase
Service
Benefits

Shared norms & standards

Project Phase
Service
Benefits

Services SWISS AUTHORIZED REPRESENTATIVE (CH-REP)

#0

Kick-off

pre-project phase

#1

Design Input Require­ments

Design & Development

#2

Design Freeze

#3

Design Trans­fer