What changes did the update of DIN EN ISO 13485 bring?

Excerpt from the most important changes of the new DIN EN ISO 13485: Additional regulatory requirements in the areas of validation, verification, design and development Risk management is given greater consideration within the quality management system Requirement for software validation is made more explicit

Do manual processes in medical technology need to be validated?

According to the regulatory requirements of ISO standard 13485 and the Quality System Regulations of the FDA, processes whose process results are not (sufficiently) verified or cannot be verified require validation - regardless of whether the process involves manual activities. Manual processes must therefore be considered in exactly the same way as automated processes.

What is a design history file and what needs to be considered when creating one?

The Design History File (DHF) represents a record of the development history and development results of a medical device. Specifically to be documented include: Intended Use of the Product Requirements and their detailing with specifications Design description and operation Construction drawings Test plans for design verification Test plans for design validation

How can an efficient supplier management be structured for the quality assurance of outsourced processes?

In practice, supplier management can be structured in several stages and include the following steps: Create evaluation catalog for supplier selection Carry out supplier qualification Select suppliers Establish supplier monitoring Supplier selection Supplier monitoring

Knowledge from the field of sensor testing

The Sensor Testing knowledge area describes the necessity and highlights the benefits of external testing of customer sensors.

Here you will find answers to the following questions:

Definition sensor testing
Why is sensor testing advisable?
What is the advantage of external sensor testing?
How often should sensors be tested?

Definition Sensor Testing

At Testo Industrial Services, we understand the term sensor testing to mean the examination and validation of a sensor. This involves analyzing the actual functioning of the sensor in order to be able to make statements about the response behavior, performance and accuracy.

Why is sensor testing advisable?

The primary aim of sensor testing is to analyze the properties of the sensor and thus ensure accuracy and reliability. In addition, the functionality and performance of the sensors becomes visible. This makes it possible to make well-founded decisions about their use and get the optimum performance of the sensor.

What is the advantage of an external inspection of the sensor system?

Independent studies strengthen confidence in the quality and reliability of your products. An external view also provides a broader perspective and an unbiased assessment.

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How often should sensors be tested?

It is advisable to carry out regular sensor testing. This allows vulnerabilities to be identified and overcome promptly. The introduction of new products or new batches is a good time to check the reliability of the sensor technology. Testing is also recommended before a new sensor type is added to the portfolio.