The characteristic of the user interface that ensures effectiveness, efficiency and user satisfaction in the designed usage environment. (Source EN/IEC 62366-1 3.16)
The characteristic of the user interface that ensures effectiveness, efficiency and user satisfaction in the designed usage environment. (Source EN/IEC 62366-1 3.16)
Usability is important for medical devices because it can impact patient safety and treatment outcomes. A poorly designed device can lead to errors, delays, and inefficiencies in clinical workflows
Usability testing for medical devices can be conducted through user observations, surveys, and feedback sessions. It is important to involve a diverse group of users, including those with disabilities or limited mobility.
No, but it is recommended. It is more costly and time-consuming to correct design flaws found in the usability evaluation of the final product. When developing a user interface for a new product, it is necessary to learn which designs will fail and why before fully understanding how to design the best user interface for the device.
The summative usability evaluation is performed during the finished product lifecycle. It is intended to evaluate the user interface implemented at the end of the development of the user interface in order to obtain an objective evaluation that the user interface is used safely. (Source EN/IEC 62366-1 3.13)
All clauses 5.1 to 5.9 of the EN/IEC 62366-1:2015 standard apply. It serves as a final check that potential problems have been identified and adequately resolved.
As required by the MDR and EN ISO 13485:2016, each process must be performed by a competent person. This competence must also be proven. This competence can be demonstrated through training or experience.
Transport validation is performed to examine the suitability of packaging compatibility and safety. Environmental influences to which the medical device is exposed during transportation and storage must not affect its function and properties. The medical device must be undamaged, maintain sterility, be free from physical damage, be free from biological contamination and function as intended. In transport validation testing, the medical device is subjected to a variety of simulated environmental conditions to check whether the medical device can withstand them without any damage to the package and the characteristics of the device.
Yes, medical device manufacturers must ensure that the medical device is packaged in such a way that its properties and performance during its intended use are not adversely affected during transport and storage. (Source: MDR-Annex 1 GSPR)
This depends on the breadth of your product range. Worst-case condition samples can be selected by first identifying the transport risks. The rationale for this selection should be stated in the documentation.
The tests specified in the ASTM D4169-22 standard simulate the effects a product will be exposed to during transportation. Therefore, you can perform the tests in an in-house or outsourced laboratory environment. Since the tests require special equipment and expertise, outsourced laboratories are generally preferred.
It allows you to review your box and packaging design in advance. You will take the necessary precautions before a real order. The loss of the finished product and the medical device during the order is more costly and time consuming than the packaging itself.
As required by the MDR and EN ISO 13485:2016 standard, each process must be performed by competent personnel. This competence must also be proven. This competence can be demonstrated through training or experience.
It is a set of documentation describing the design and development activities of a medical device.
Start preparing documentation that is up to date which meets the requirements of MDR and EN ISO 13485:2016 and includes all design phases.
For this process, it is recommended to conduct a usability study in accordance with EN 62366-1:2015 standard. User needs help you create the framework for your medical device product design.
Medical device manufacturers can improve design by incorporating user feedback and conducting rigorous testing throughout the design process. They can also prioritize user-centered design and work with healthcare professionals to better understand the needs of patients and clinicians.
If a sample number is not specified in the specific standard of the test to be performed, the number of samples to be used must be statistically significant.
Verification is the confirmation through inspection and provision of objective evidence that specified requirements are met.
Validation is determining with objective evidence that a process consistently produces a result or product that meets its predetermined specifications.
Simply put, process verification proves that you are creating the right product, and process validation proves that you are creating the product right.
Since the design of the medical device will influence your validation, it is necessary to start the validation process as early as possible in the design phase.
Risk management plays an important role in process validation by helping to identify and mitigate potential risks to the manufacturing process. Manufacturers should conduct a risk analysis to identify potential sources of variability and assess their impact on device quality and safety. This information can be used to design and implement appropriate controls to minimize these risks.
IQ, OQ and PQ are the three phases of process validation, which stand for Installation Qualification, Operational Qualification and Performance Qualification respectively. Installation Qualification verifies that the equipment and software are installed correctly, Operational Qualification verifies that the equipment operates within specified limits, and Performance Qualification verifies that the manufacturing process can consistently produce a high-quality product.
It is the method for investigating or evaluating a user interface with intended users within a designated designed usage environment. (Source EN/IEC 62366-1 3.19)
Unfortunately, there is no single answer to this question. In order to decide this, it is necessary to first create a usability protocol according to the EN / IEC 62366-1:2015 standard and apply the methods recommended by the standard to reduce the usability risks of the product. However, among all these methods, usability testing with real users is one of the best risk mitigation methods.
Formative usability evaluation enables the identification of issues and challenges through an iterative process. It optimizes the user interface of the device. All clauses 5.1 to 5.8 of the EN/IEC 62366-1:2015 standard apply.
Formative usability evaluation is performed during the design phase of your product. You can also include your prototype product in the formative usability study. By repeating the formative usability study, you ensure that the anticipated risks are mitigated. Think of the formative usability study as a prototype before the summative usability study.
It is performed for products designed before the standard publication date which are already on the market. The following steps are performed:
The point to be considered here; if there is a design change, this method is used for the unaffected aspects. Also, it cannot be used if there is not enough data.
Common usability issues with medical devices include poor user interface design, unclear instructions or labels, difficulty in cleaning and maintaining the device, and issues with compatibility with other devices or systems.
Yes, devices with a specific microbial state should be packaged in such a way as to ensure that they remain in this state when placed on the market and that they remain in this state under transport and storage conditions. (Source: MDR-Annex 1 GSPR)
The planning process of transport validation should start at the design stage. If you are not sure about the packaging and boxing design of the medical device during this process, we recommend that you proceed to the finished product stage with the correct design by performing simulation tests. This will save you from future cost and time loss.
Finally, the transportation process needs to be validated by considering the current order points of your finished product.
Unfortunately, there is no standard describing transport validation test methods specific to medical devices. The manufacturer must choose what all tests to apply to their devices to demonstrate safe and effective transport.
The most commonly used in the US and Europe is the DC 13 pathway as specified in the ASTM D4169-22 standard.
In addition, ISTA 3A tests are also performed.
Yes, if you can mitigate all the foreseen risks. For example, you sent your medical device to a region by truck on a standard route and brought it back. In this process, you have not considered the following hazards.
Therefore, before starting transport validation, we recommend performing a risk analysis and evaluating it within the framework of the protocol.
The first cost reason is that the test equipment that performs simulation tests are costly and comprehensive devices. However, it is generally seen in the cost analysis that our manufacturers go to a more costly process in case of damage in real transport processes without simulation tests.
Both the medical device manufacturer and the transport company have responsibilities for ensuring that devices are transported safely. The manufacturer is responsible for designing and testing devices to withstand transport conditions, while the transport company is responsible for handling and delivering devices according to agreed-upon conditions.
Within the scope of EN ISO 13485:2016 standard, it is necessary to carefully implement each step below.
1- Design Planning
2- Determination of Design Inputs
3- Determination of Design Outputs
4- Design Review
5- Design Verification
6- Design Validation
7- Design Transfer
8- Recording Design Changes
The design controls prove that your medical device is designed to meet the needs of its users and patients and that it meets applicable standard requirements and performance criteria.
Today, there are incubation centers in our country that provide equipment and environment from designing medical device products to prototyping. What should not be forgotten when making a choice here is that working with an expert team with knowledge of medical device regulations and standards will save you from cost and time loss in the future.
Manufacturers can ensure successful process validation by engaging cross-functional teams and subject matter experts throughout the process validation phases, and by performing extensive testing and analysis using statistical analysis to optimize the manufacturing process. It is also important to maintain accurate records and documentation throughout the process validation process.
In process validations in general, not all critical quality attributes are equivalent in terms of risk. Some may have a minor impact on patient safety, while others may have a major impact. Higher sample selection should be applied to critical quality attributes of high importance compared to critical quality attributes that are determined to be of low importance.
Any process with measurable process outputs can be validated. For example
Process validation can contribute to continuous improvement by identifying opportunities to optimize the manufacturing process and reduce variability. By collecting data and monitoring performance over time, manufacturers can identify trends, patterns and areas for improvement. This information can be used to make changes to the process and improve its efficiency and effectiveness.
Some common mistakes in process validation include inadequate planning, inadequate data collection and analysis, failure to identify and control sources of variability, and lack of collaboration between different departments or stakeholders. To avoid these mistakes, it is important to prioritize proper planning in process validation and ensure that it is executed effectively.
Manufacturing a medical device outside the validation parameters can have serious consequences for patient safety, product quality and regulatory compliance. If a device is manufactured outside the validated parameters, it may not meet the intended use, safety and efficacy requirements and may pose a risk to patient health. Furthermore, manufacturing a device outside approved parameters may result in non-compliance with regulatory requirements, which could result in legal or financial penalties. In extreme cases, failure to manufacture a device within approved parameters can result in product recalls, harm to patient health and damage to a company's reputation. It is critical that medical device manufacturers prioritize process validation and adhere to the parameters established during the validation process to ensure product quality and patient safety.
