Before a product receives market approval or certification, it undergoes a qualification process in which its production readiness is assessed through various tests. In the verification phase, it is checked whether the product complies with the specified ISO standard specifications. Validation follows verification and is a type of field test or validity check. During initial sampling, test subjects evaluate components and products with regard to performance goals such as function, quality, or safety. In this phase, M.TEC takes charge of managing and monitoring all processes, both on a technical and regulatory level, with a 360° perspective.
Do you need support in verifying production tools, individual parts, or assemblies?
Many products or components belong to industries that are strictly controlled before a documented qualification takes place. From the beginning of product development, standards, rules, and laws play a significant role. As part of the verification, M.TEC not only checks whether the product meets the set specifications but also whether the underlying development processes and production procedures comply with the requirements. Discrepancies can be identified and corrected early.
Are you looking for support in validation planning and implementation?
After successful verification, the validation phase begins, in which the product is tested by end users to check if it truly meets customer satisfaction and needs such as durability, reliability, and user-friendliness. The collected data not only confirm the product's suitability for use but also identify potential improvements.
Verification and validation as an integral part of efficient concept development of premium products by M.TEC!
Would you like to consider verification and validation independently or simultaneously? M.TEC uses the "predictable quality" method for this. After all demands on the product have been considered in the concept and all solution approaches have been weighed in the development, it is clear how the product should be mechanically constructed. M.TEC provides strategies and concepts for quality assessment and monitoring for both processes, both in meeting specifications (verification) and in achieving usage goals (validation). Our engineers provide decision-making bases by capturing relevant parameters as precisely as necessary and realistically replicating stresses in the shortest possible time. The development of qualification processes includes not only the actual design of the process or test equipment but also component research, procurement, and implementation.
Our method of "predictable quality" essentially includes:
- Identification of quality-relevant product features
- Development and design with valid, measurable characteristics
- Definition of measuring tools for mass production
- Development of test methods to map functional requirements
- Design and construction of testing equipment
- Support of measuring tool qualification
M.TEC develops successful products of tomorrow with a holistic methodology. Regular re-validation of sensitive system properties is part of this. Certain tests must be repeated regularly during mass production because of their importance for product safety, product quality, or product approval. Typical examples include safety technical controls (STC) for medical products and volume tests for approval in certain regions. Furthermore, supplied parts can exhibit quality fluctuations, which can affect the overall product. In series tools, wear can occur after some time, so tolerances may no longer be maintained.
M.TEC supports you in all aspects of verification and validation with commitment and over 30 years of experience. Feel free to contact us.