Testing of a manufacturing process for its applicability
During Validation or an installation, a Device or a manufacturing process is reviewed for its capability to achieve the specified intended use.
Product, Software and Process Validation - do you know the difference?
- Do you know the difference between Medical Device software and process Validation?
- Do you know which processes require Validation? Where does it make sense and where can it be omitted?
- Are you familiar with the phases of a Validation (IQ, OQ, PQ) and the associated contents and requirements?
- How do you get a sampling plan that the Notified Body accepts?
Product or Design Validation - Are we developing the right Medical Device?
During product or design Validation, we investigate whether the right Medical Device has been developed or not. It must be assessed and proven that the Medical Device meets the intended purpose as well as the user-specific requirements. Among other things, these aspects should be taken into account:
- Usability Validation
- Software Validating
- Clinical Evaluation
- Representative units of the pilot series
The supportive documents, which must be created during Validation, are the core of the Technical Documentation. Together with the Verification documents, they prove that the essential requirements for the safety and performance of your products are met.
Process Validation according to EN ISO 13485 and 21 CFR 820.75
A Process Validation must always be used if Medical Device properties or the results of a process cannot be confirmed in the finished Medical Device. However, a Validation of the manufacturing process can check how consistent and replicable it is to produce a specific Medical Device. Continuous Validation must therefore provide documented proof that a process permanently complies with its specifications.
A process that has been proven to work and deliver the intended result is a Validated process.
qtec as your partner
Our approach to a compliant and effective Product Validation is:
- QM System evaluation
- The process steps are described in the process instructions
- There are templates available for documentation, from the Validation plan to the execution and report
- The statistical approach is described and justified
The performance and safety of your products are ensured by clear, well-structured test plans, complete documentation of the tests and above all, an evaluation of the results discussed in context.
We will support you with:
- The implementation or optimization of your Validation processes
- The implementation of Validation activities
- The creation of Validation documents
- Train your employees in courses or workshops and thus help them to help themselves.
- Which clinical strategy do I use to evaluate my software as a medical device according to MDCG 2020-1? We know the regulatory requirements.
- Areas: Europe, Worldwide / Updates, New regulations and guidances 31/22
- Life Cycle management tool support in medical technology. DOORS, RQM or ELM - correctly manage requirements, tests, documentation and traceability.
- Areas: Europe, Worldwide / Updates, New regulations and guidances 20/22