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QUALITY SERVICES

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We relieve you by further development-related services and thus drive your products forward

In addition to our core competencies of product development and testing, we support you with further accompanying services. True to our commitment to service excellence, we strive to identify your needs and wishes and to offer suitable solutions. Our goal is to relieve you as much as possible during the entire development process.


We present a selection of preferred services here. Do not hesitate to ask us for other support  – we will give you a realistic assessment of our abilities.

Our services at a glance:

Risk Management

Risk Management

Risk management is an integral part of the development and manufacture of medical devices. The increasing complexity of the systems and the associated susceptibility to errors must be addressed effectively and safely. Risk management starts in the concept phase of a development –  we analyse potential error cases and their probability for you: from individual components and interfaces to the entire product. In addition, we support you as part of the risk analysis in risk assessment and risk control according to ISO 14971.

FMEA-Moderation

FMEA-Moderation

You already use FMEA as a tool during the project, but you are dissatisfied with the performance?

We are happy to advise you on the basic structure of an effective FMEA system in your company and support you through the FMEA moderation. Our invenio moderators are experienced and specially trained developers. They take over the preparation and follow-up of the FMEA sessions and carry out these examinations in your software system (Apis iQ-FMEA or PLATO SCIO-FMEA)  –  at your site.

Technical Documentation

Technical Documentation

We support you with development-related documentation including change and version management. We are happy to create or edit the following types of documents for you:

  • Requirement Specifications, Functional Specifications
  • Process flow Diagrams, function structures
  • Risk Analysis, FMEA Forms
  • Technical Reports (e.g. test reports, root cause analysis)
  • Technical Drawings and Parts Lists
  • Design History File (DHF)
  • Device Master Record (DMR)

We offer the use of synergies by editing the documentation parallel to the development. This relieves the burden on the developers, but nevertheless ensures that all development steps are logged efficiently that the documentation is completed promptly and can be released when the design phase is completed.

Innovation Workshops

Innovation Workshops

Are you looking for innovative solutions and fresh ideas every day? As part of our wide-ranging development projects, we engage almost daily with innovations and creativity techniques to develop novel and individually tailored concepts. Use our strength in joint workshops.

Our services at a glance:

  • Prepare and plan suitable creative methods
  • Moderate the interactive workshops
  • Optional participation of experienced invenio developers
  • Elaboration of the generated ideas into patentable concepts

Quality Consulting

Quality Consulting

Our quality team is responsible for our DIN EN ISO 13485 certified Quality Management System. With the know-how, the team also supports customers in various projects.

We offer you the following portfolio:

  • Release-ready preparation of equipment and devices' qualification
  • Create rational documents to evaluate facts logically and conclusively
  • Gap or Impact Analysis of standards and guidelines
  • Advice on setting up and maintaining a QMS in accordance with DIN EN ISO 13485
  • Create and optimize SOPs and forms

If you have a task that requires standard knowledge and the ability to connect and document analytical insights with the topic, then feel free to contact us. Above all, we see our competencies in such challenges.

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