You have the the critical topic

We find the solution

Whenever it gets really difficult
and one or the other is struggeling...

...then we feel comfortable

Our Services

Speed-Up your Development

velixX supports development projects of medical devices by offering:

  • Consulting Services for Health-Care Innovators
  • Feasibility Studies
  • Technical Support – Firefighting
  • Development and Industrialization of disposable parts
  • Technical Module or Product Development

NextGen Development: we know that most challenges in diagnostics and device development arise today at the interface where e.g. biochemistry, biomaterial, technology and disposable interact with each other. That’s why our development teams are built with experts and senior specialists not only from velixX but from a wide network of research institutes, manufacturers, designers and more.
With the best experts for each specific topic, we support you exactly where you need while minimizing development time and cost.

IVDR – Support

Since the 25th May 2017 the In-Vitro Diagnostic Regulation is in place and every product must become IVDR conform latest till 2022. velixX is able to support you, either in the process to adapt your products and your documetation to fit into the IVDR conformity or in realizing a fully conform new product development fullfilling the new IVDR. Our long term experience in international product development, allows us to optimize your processes and documentation in cost and time.

Consulting Services for Health-Care Innovators

In 25 years we have gathered extensive experience in developing innovative medical devices and market introduction. With our consulting services we pass that experience on to you: The most critical aspects of development, manufacturing, regulation or a review of the status quo make sure you get a head start in your development process.

Feasibility Studies

velixX can verify technical feasibility reliably and in a short period of time. Potential solutions are built quickly as prototypes and evaluated by including technical specialists, experts and manufacturers. All documentation is always set up to be compliant with MDR as well as FDA requirements.

Technical Support – Firefighting

velixX supports your development project with respect to the real critical technical issues. With the most recent methods and tools for system analysis and supported by our network of experts, we analyze potential weak spots, optimize regarding functionality and producibility and verify manufacturing and testing processes. Our specialization in the interface of technical fields allow us to take a holistic approach and derive an action plan that can be executed immediately.

Development and Industrialization of disposable parts

Plastic parts often have important system-critical functions and at the same time must be produced at very low unit costs in large quantities. Often it is a critical element in medical technology and diagnostics to design them functionally and process-oriented such that they can be produced and tested reliably in high volume.
Whether it is a connection technology, biochemical functionalization, coating, sealing, sterilization or packaging, exactly the best methods are found everywhere.

Technical Module or Product Development

You don’t need just support but want to outsource development of an entire device? We are happy to take over development projects for device modules or complete systems.
With NextGen Develeopment we set up and manage effective teams that are tailored to your project and temporarily add further specialists if needed. We start by extensively clarifying the requirements together with you, and create a complete risk management plan.
The technical excellence of our development partners guarantees fast and customized solutions, ready to produce. Each major project is accompanied by an independent expert team for quality management and regulatory affairs to meet MDR and FDA criteria.
Nevertheless, we at velixX will be your single point of contact throughout the project and manage everything else for you until your new device is ready for market introduction.

Our Expertise

We think in Systems

  • Human-Material – Disposable – Device
  • Biology –  Mass-Production – Technical Solutions
  • Biochemistry – Plastics – Optics
  • Reagents – µ-Technology – Physics – Measuring-Technology

We manage Complexity

  • Systemanalysis
  • Projectmanagement
  • Partnership-Management
  • Supplier-Management
  • Coordination of Interfaces
  • Following the V-Model

We make things available quickly

  • Machine Shop
  • Rapid Prototyping
  • Small-scale Production
  • Electronics Laboratory
  • Huge Partner Network
  • Short Decision Pathways

We support the whole process

  • Industrial Design
  • Project Support
  • Development of Medical Devices
  • Design of Product & Disposables
  • Design of Process Chain
  • Producibility & Production Cost Optimization
  • Selection of Manufacturers
  • Assembly & Machine Tests
  • Test Stand Development
  • Prototype Testing
  • Quality Reports
  • Technical Documentation (according ISO and FDA)
  • Technical Information Manuals for Service & Marketing

Quality Standards

All of the specifications and documentations, which we create, comply with the usual quality standards and guidelines of the medical technology. The corresponding certifications are in progress.

  • DIN EN ISO 13485:2016 in preparation (goal: 2018)

Contact

Ansprechpartner: Manfred Augstein
Wildbader Straße 7
68239 Mannheim
Telefon: 0621 / 437 08 001
E-Mail: mail@velixx.com

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