We gear our development to your goals
Our development process is based on the following fundamentals:
- Design Control Process (FDA 21 CFR 820.30 and Sub-clause 4.4 of ISO 9001)
- DIN EN ISO 13485
- VDI guideline 2221
- Simultaneous | Concurrent Engineering
- Our invenio experts' many years of experience
On this basis, we offer you development in full with the best possible flexibility. We adapt to your specific requirements and use them to create templates, gates and reviews. In addition, we provide intellectual property that can be legally protected – the rights are of course passed on you.
The transfer of our know-how to you is the core of a successful development for us! To ensure this, you are always pro-actively informed about the project status and details of development. We also support you in interdisciplinary communication, including quality management, risk management and production planning. For important decisions, we prepare a solid decision basis and actively involve you in the process.
Our invenio development process is conceptually divided into five phases:
Requirement Phase (User Needs)
Already in the early discovery of innovative products or expansion of your portfolio, we support you in the generation of ideas, the preliminary studies and the determination of requirements.
- Preliminary study and model creation
- Requirements Engineering (user and product requirements, regulatory requirements, standards and laws)
- Risk Analysis and Management
- Creating detailed specifications
Specification Phase (Design Input)
The 'Specification Phase' includes, among other things, the creation of concepts using situationally selected methods and the testing of feasibility. The goal is to record the later technical implementation in the specification.
- Innovation Workshop
- Methodical Concept Development
- Analytical Testing of Viability
- Early Preliminary Tests to evaluate and select the concept approaches
- Consideration of conformity to product-specific and harmonized standards
- Derive the Validation and Verification plan (VVP) for the organization of requirements and their review
- Review the development in terms of Risk Management and Implementation of accompanying FMEAs by the Quality Services Team
After reviewing the requirements specification, we will translate your requirements into a suitable design – including the step-by-step verification of the design specifications. invenio offers everything from a single source: Mechanics, electronics and software.
- Design, analytical and numerical calculation (FEM) and simulation
- Create electronic block diagrams, isolation charts, schematics and layouts
- Component search and production of the prototype board including programming of the software
- Set up handling or usability prototypes
- Implementation of individual and overall functions in the context of functional and laboratory prototypes
- During the course of development: testing for risk minimization and pre-verification according to the product-specific Validation and Verification Plan (VVP)
- Mechanical and electrical tests to verify compliance with standards (eg IEC 60601-1, IEC 61010-1) or specific requirements
- Early involvement of Production Planning, Risk Management, Quality Management and other units throughout the Design Process
During the 'Design Phase' the structured transfer of the development results to the production takes place.
- Passing the specifications with your or our production
- Developing the devices and fixtures for manufacturing, assembly and testing preparation of assembly
- Preparation assembly instructions and test instructions
- Verify Design Input and Design Output by qualified testing and experienced testing experts
invenio also serves as a competent partner in the field of validation.
- Creation of test cases, questionnaires and evaluation of the field test
- Technical support of field devices and products
- Derive requirements and solutions from user feedback