Types of contract
Our types of contract
Contract for work, Service contract or Employee assignment
We are the strong partner for manufacturers of medical devices. Our team, currently comprising almost 100 experts, advises and supports your company throughout the entire MDR journey – and beyond. From our consulting services over support in the development process to the provision of external risk managers: our different contract types enable you to tailor our joint cooperation specifically to your individual requirements and necessities. Whatever challenge you may face – we have the solution.
Contract for work
- a qualitative customizable work is agreed and created
- qtec creates the work through the qtec experts under sole responsibility and according to its own plan. That means qtec independently defines the
- organization of the work
- time-wise disposition
- number of qtec experts
- eligibility of qtec experts, etc
- The qtec experts are basically free from directives and can decide on their own working hours. qtec only receives directives which refer to the performance of the work.
EXAMPLE: Writing a complete clinical evaluation
Service contract
- A specific service is owed
- qtec performs the owed service through the qtec experts under sole responsibility and according to its own plan. That means qtec independently defines the
- organization of the work
- time-wise disposition
- number of qtec experts
- eligibility of qtec experts, etc
- The qtec experts are basically free from directives and can decide on their own working hours.
EXAMPLE: Explorative testing of new software functions during development
Employee assignment
- the qtec expert is integrated in your work organization
- the qtec expert is subject to your directives
- the qtec expert is deployed like your own employees according to your ideas and goals
Attention: If an employee assignment exists after a judgmental overall view of all circumstances but a contract for work or services was concluded, a penalty of up to 50,000 € is threatened according to the Temporary Employment Act (AÜG).
EXAMPLE: External project manager
News
Opportunity and challenge: Regulatory requirements for AI-based medical devices
AI has the potential to revolutionize healthcare and improve the lives of millions of people - but only if it is used safely and reliably.
Common Criteria for Information Technology Security Evaluation
Common Criteria (CC): International IT security standards for medical devices, supported by BSI and BfArM, enhance cybersecurity and trust in processes.
Clinical evaluation of eyeglasses
Both prescription and non-prescription eyeglasses are considered medical devices under the regulatory framework of the Regulation (EU) 2017/745.
Clinical Evaluation for Medical Devices in China
The field of medical devices is rapidly evolving, and as technological advancements continue, so do the regulatory frameworks governing their approval and marketing.