Headerbild evos: Mann an einem Bergsee mit Aussicht auf eine Berglandschaft

exploring new horizons

Jointly with our partners, we create future-oriented and innovative medical devices.

Icon Projektmanagement

Project management

Icon Engineering

Engineering

Icon Produktverifizierung

Product verification

Icon Prozessvalidierung

Process validation

Icon Technische Dokumentation

Technical documentation

From the idea to the finished product.

Customized support for start-ups and innovative medtech companies
throughout the entire development process.

Project start phase

Bild Project Initiation

You have an idea for a new product or you need help to optimize your product and you are looking for competent support in its implementation. Our team helps you to detect the opportunities and risks of a technical implementation and how to use them positively. Crucial for this is a structured analysis of the project to obtain all the necessary information and requirements at an early stage so that a project can be successfully implemented. To give the project the best possible start, we create:

Icon Check

Project planning (time, milestones & budget)

Icon Check

Requirements engineering (user & stakeholder requirements, technical standards)

Icon Check

Risk management plan

Icon Check

Usability plan

Icon Check

FTO assessment

Product development

Bild Produktentwicklung

Product development is one of our most important core competences. Thanks to our many years of experience in the development of medical products and an extensive national and international network of competent partner companies, we quickly and reliably can provide innovative solutions for a new product. Our development process follows the strictly guided specifications of a quality management system according to ISO 13485. Within the scope of technical development, we offer:

Icon Check

Mechanical/Design engineering

Icon Check

Development of electronic hardware and software

Icon Check

Risk management (e.g. risk analysis, dFMEA)

Icon Check

Test bench development

Icon Check

Functional testing, Proof-of-Concept

Icon Check

Design Freeze Evaluation

Process development

Bild Process Development

Product developments are always accompanied by the development and implementation of the corresponding manufacturing processes. In doing so, we also check the application of new innovative production technologies taking qualitative and economic factors into consideration. The subsequent testing and confirmation of process reliability is an essential part of our service.

Icon Check

Transfer of product development into series production

Icon Check

Development and implementation of innovative manufacturing processes

Icon Check

Implementation of quality assurance (test plan development & supplier qualification)

Icon Check

Risk analysis and pFMEAs

Icon Check

Design, construction and qualification of manufacturing tools, operating and handling equipment

Icon Check

Process capability analysis using statistical methods

Icon Check

Prototyping

Icon Check

Planning and implementation of process validations
(IQ / OQ / PQ)

Verification & Validation

Bild Verification & Validation

Before the new product is approved and can used, it must undergo extensive verification that the product meets all requirements. Careful planning of these verification tests is crucial for efficient use of time and resources so that the product can be approved safely and quickly. Jointly with our partners, we offer a wide range of verification tasks:

Icon Check

Verification Master Plan

Icon Check

Design and construction of individual test benches

Icon Check

Conduct design verification tests: functional tests, stability, durability and usability, etc.

Icon Check

Preclinical studies (in vivo tests)

Icon Check

Manufacture, commissioning and qualification of test stands and test equipment

Our services

Icon Projektmanagement

Project management

  • Planning and budgeting of development projects
  • Project leadership
  • Monitoring and steering of subcontracts to external partners
  • Supplier qualification
Icon Engineering

Engineering

  • Development of products, sub-components and manufacturing processes
  • Mechanical design (3D CAD design)
  • Electronic hardware and software development
  • Device & method development for manufacturing and quality assurance
Icon Prototyping

Prototyping

  • Development and production of functional samples, individual single products/devices and small series
  • Design and manufacture of mechanical devices, equipment and test benches
  • Own mechanical workshop (turning lathe, milling machine, machining of metals + plastics)
  • Rapid-Prototyping
Icon Simulation

FEM-Simulation

  • FEM simulations during development for design evaluation
  • Linear/non-linear statics
  • Heat transfer
  • Modal analysis
Icon Produkttestung

Product testing

  • Planning and development of test methods for product testing
  • Development and manufacture of test fixtures and test equipment
  • Independent implementation of product tests within the scope of design qualifications
  • Preparation of test reports
  • Tensile tests
  • 3D coordinate measuring system
  • Surface characterisation by means of 3D profilometer (contactless measurement of contours, flatness and roughness)
  • Surface characterisation by means of tactile surface determination
Icon Prozessvalidierung

Validation of processes and systems

  • Planning, implementation and documentation of software validations (CSV)
  • Validation of specific processes, for example bonding, welding and cleaning
Icon Technische Dokumentation

Technical documentation

  • Creation and review of documents of the product file relevant to approval
  • Description of processes and methods (process-, work-, test procedures)
Icon MDRIcon FDA

References & Partners

Logo mecoraReferenz OsypkaReferenz ProtembisReferenz sphair lab
Schriftzug Erich-und-Hanna-Klessmann StiftungPartner Horizon 2020
Logo evos GmbH
Teamfoto evos: Alle Mitarbeiterinnen und Mitarbeiter der evos GmbH

Jointly with our strong national and international partner network, we have been successfully developing medical devices at the technology location of Aachen for more than 20 years.

An agile and multidisciplinary team forms the basis for supporting our clients as a highly dynamic and flexible organisation.

Being strongly solution-oriented and transparent, we can also quickly fulfill individual customer requests through flat and efficient communication structures.

Foto Andreas Henseler

Andreas Henseler

ahenseler@evos-gmbh.de

Foto Heiko De Ben

Heiko De Ben

hdeben@evos-gmbh.de