Design Control
Requirements Engineering and Management
Definition and verification of requirements
We understand Requirements Engineering and Management as a continuous process. If this is properly structured, the requirements are formulated precisely and can be evaluated objectively.
The path of the requirement from customer request to the developed product.
Requirements engineering and management is a structured approach:
- To create
- Document
- Check and coordinate
- Link
- Manage Requirements
Based on the stakeholder requirements
(problem area)...
- Typical customer requirements (CRS, URS)
- How does the Medical Device have to perform?
- What does the customer/user do with the Medical Device
- Stakeholder wishes and perceptions
- Regulatory and normative requirements as well as requirements from risk management are taken into account
- The product is validated against the stakeholder requirements - "Has the right product been developed?
These are the minimum requirements you should have:
- Standards requirements (Especially for the approval of Medical Devices it is difficult to identify and keep track of all applicable standards with thousands of requirements.)
- Risk requirements ( A Medical Device must not pose a foreseeable hazard. However, the question of what is acceptable, is not so easy to answer.)
- User requirements (understanding and describing what the product users want or need is one of the main tasks of Requirement Management. However, it is just as important to consider the customer and all requirements of other stakeholders from the very beginning.)
the way leads over the Medical Device requirements...
- Technical System Requirements (TSR, SysReqSpec):
- What has to be done (technically) to reach the Medical Device characteristics required by the stakeholder?
- How does the Medical Device (=system) implement the stakeholder requirements?-General understanding and language of the system engineer and developer; traceability for the customer
- The system is verified against the system requirements. "Has the Medical Device been developed correctly?"
the design specification (solution space).
- How are the functions and features of the Medical Device implemented?- Domain of the developer
the overarching linking of requirements
- Traceability - Traceability ensures that the connection between the original requirements, the subsystems, the Medical Device tests and their results are documented in a traceable manner at all times.
Challenges in requirements engineering and management- Do you know what they are?
The Medical Device is ready, yet the requirements are not; this leads to statements like: "This happened with the last Medical Device as well." Because of this, you find yourself questioning whether or not requirement engineering makes any sense at all for you and your company.
The attributes that reflect the quality of requirements include: "complete", "correct", "understandable", "unambiguous", "consistent", "structured", "atomic", "testable".
If these properties are not fulfilled, requirements must be corrected and redefined during the course of the project, meaning during ongoing implementation and verification, and the existing structure, the requirements must be modified. This can be a source of error for the:
- Overall structure of the requirements
- Assignment of requirements to test cases and other elements
- Definition of acceptance criteria (expected result) of the test cases
qtec as your partner
We know the feeling.
Our approach is: good Requirement Engineering is to be understood as a process that should be established cleanly. And a clean process ensures that the technical solution really meets the customer's requirements.
Essential for this, is the following:
- A requirement is an element of a defined system architecture and is distinguished between functional and non-functional requirements
- The interfaces within the architecture are clearly described and also linked (traceability)
- The requirements have been formulated clearly, consistently and in a testable way
How can we help you? We offer our customers requirements management as a single service or as an all-inclusive package. This means that we support customers from specification and testing to the finished file and approval of the device. This is by no means something that can be taken for granted on the market. With our many years of experience and a widely linked network of know-how carriers, we can offer this extensive service even for large companies as well as all around Europe.
News
Regulatory Affairs Update 25/23
Areas: Europe, Worldwide / Updates, New regulations and guidances 25/23
Regulatory Affairs Update 15/23
Areas: Europe, Worldwide / Updates, New regulations and guidances 15/23
Post-Market Surveillance in China
In China, Post Market Surveillance (PMS) is an important component of the regulation for medical devices, ensuring the safety and effectiveness of these products.
Regulatory Affairs Update 05/23
Areas: Europe, Worldwide / Updates, New regulations and guidances 05/23
