Your path to safe approval with verification, validation & quality assurance

1. analyze requirements - identify risks before they become expensive

We start by clarifying: What does the system have to do - and where are the risks? This clarity saves expensive loops later on and ensures that your project gets off to a structured start.

• Definition of safety-related requirements (IEC 61508, EN 50126, EN 50128/ EN 50716, EN 50129, EN 50159)
• Risk analysis to avoid project delays
• Verification & validation planning as a common thread

Your advantage: No surprises - you start on a solid foundation.

2. verification - "Are we building the system correctly?"

Errors in implementation cost time, money - and nerves.
We consistently check your system against the specifications. Every step is comprehensibly documented and ready for an audit.

• Systematic review of all relevant requirements based on the verification plan
• Systematic testing (including code reviews for error prevention, performance testing, software error impact analysis, black box testing, interface testing, traceability)
• Verification in accordance with current standards (IEC 61508, EN 50126, EN 50128/ EN 50716, EN 50129, EN 50159) and creation of a verification report. In this way, we ensure that your system meets the specified requirements exactly - right from the start.

Your advantage: No surprises - you start on a solid foundation.

3. validation - "Are we building the right thing? "

A system or software can be technically perfect - and still not be approved.
Our validation ensures that your systems or software are really suitable for the intended use - and that the approval authority sees this in black and white.

• Validation under real operating conditions
• Systematic review of all relevant safety requirements based on the validation plan
• Continuous documentation as proof for approval.
• Qualified safety validation in accordance with all relevant standards
• Creation of valid, authority-compliant reports

Your benefit: Your system not only works - it also meets all regulatory expectations.You also avoid delays in the approval process and expensive rework.

4. quality assurance - because "almost good enough" is not enough

A lack of quality costs more than you think - often at the very end.
We integrate end-to-end quality management[(link: QM)] into your processes and help you to work efficiently and error-free right from the start.

• Customized quality strategies
• Efficient testing processes to optimize development time
• Validation according to the highest safety standards
• Smooth processes thanks to integrated QM

Your benefit: Less rework. More control. Clear test paths.

5. evidence & documentation - ready for the audit

What is not documented does not count - especially with the authorities.
We create all reports so that they meet the formal requirements and open the door to approval for you.

• Seamless verification documentation as the basis for approval
• Standard-compliant creation of safety certificates and verification reports
• Usable for internal audits & external inspection bodies

Your advantage: You will appear prepared - with convincing reports.

6. approval - without stumbling blocks to market entry

We accompany you - all the way to the green light from the authorities.
Our structured preparation ensures that assessments run smoothly. And if questions do arise, we are at your side.

• Support with independent assessments and assessments by supervisory authorities (EBA, BAV, etc.)
• Avoidance of unnecessary additional claims thanks to clean preparatory work
• Smooth approval support for a secure market entry

Your advantage: Safely to approval - efficiently and professionally accompanied.