Basler Goes ISO 13485
Basler has proven its high quality standards for the development, production, distribution and service of digital cameras with the certification according to DIN EN ISO 13485:2016. For you, this means: consistency, reliability and quality.
Whether you want to operate internationally or expand locally: The quality management standards defined for the certification in accordance with DIN EN ISO 13485:2016 can help you eliminate uncertainty, avoid unnecessary expenditures and explore new market opportunities.
With the introduction of the standard in certain organizational areas for the development, production, distribution and service of selected products, we adapted our quality management system to the requirements of the medical world. This makes it possible for us to help you with the auditing of your medical products or the preparation for the certification.
As a manufacturer of medical devices, this gives you the opportunity to acquire selected cameras from us for your applications and thus benefit from the high-quality specifications of the standard. Our cameras are suitable as image processing components and designed to record images, videos or measurement data when used as intended. They are not a medical product in the sense of the medical product law.
How can you benefit from the DIN EN ISO 13485:2016 standard?
- Everyone profits from an effective quality management system with clearly defined quality standards. To customers and regulatory authorities, this certification signals that the company is committed to high quality.
- Certification enables access to worldwide markets
- Elimination of uncertainties with clear standards
- Optimization of processes in your company
- Increase in efficiency, reduction of costs and monitoring of the performance of the supply chain
- Demonstration of safer and more effective medical products
- Fulfillment of directives regarding medical products and customer expectations
What can we offer you?
- Less expenditure for your audit and product documentation, since we cover the necessary requirements of the standard as a supplier
- Validated and monitored production for reliable product quality: The relevant components undergo comprehensive quality control, from the acceptance of the material to the entire production process all the way to shipping
- Selected provider in accordance with the quality standard, regularly monitored and evaluated
- Constant documentation quality due to comprehensive change management
- Change notification in case of unavoidable changes, which ensures the quality of the documentation
- Specification changes after prior coordination with customers, which gives you sufficient time to react with documentation adjustments for your products
- In case of recalls, lower costs and more transparency due to traceability: Based on structured recordings, cameras can be systematically traced back to the production process and can be designated as critically defined components if needed.
- Separate production line for our Basler cameras for medical & life sciences which ensures compliance with the quality management standards
- Simplified compliance with European standards for international manufacturers of medical products, since we already satisfy the regulatory requirements
- You also have the option to be informed about all relevant product changes. To opt in, please register at: www.baslerweb.com/pcn-registration
Basler cameras for Medical & Life sciences – find your perfect model
Select the appropriate model for your needs from the Basler MED ace product line:
|Camera model||Resolution (H x V)||Frame Rate||Mono/Color||Sensor|
|Basler MED ace 2.3 MP 41 color||1920 px x 1200 px||41 fps||Color||IMX249||
|Basler MED ace 2.3 MP 41 mono||1920 px x 1200 px||41 fps||Mono||IMX249||
|Basler MED ace 2.3 MP 164 color||1920 px x 1200 px||164 fps||Color||IMX174||
|Basler MED ace 2.3 MP 164 mono||1920 px x 1200 px||164 fps||Mono||IMX174||
|Basler MED ace 5.1 MP 35 color||2448 px x 2048 px||35 fps||Color||IMX264||
|Basler MED ace 5.1 MP 35 mono||2448 px x 2048 px||35 fps||Mono||IMX264||
|Basler MED ace 5.1 MP 75 color||2448 px x 2048 px||75 fps||Color||IMX250||
|Basler MED ace 5.1 MP 75 mono||2448 px x 2048 px||75 fps||Mono||IMX250||
|Basler MED ace 5.3 MP 20 mono||2590 px x 2048 px||21 fps||Mono||PYTHON 5000||
|Basler MED ace 5.3 MP 20 color||2590 px x 2048 px||21 fps||Color||PYTHON 5000||
|Basler MED ace 8.9 MP 32 color||4096 px x 2160 px||32 fps||Color||IMX267||
|Basler MED ace 8.9 MP 32 mono||4096 px x 2160 px||32 fps||Mono||IMX267||
|Basler MED ace 8.9 MP 42 color||4096 px x 2160 px||42 fps||Color||IMX255||
|Basler MED ace 8.9 MP 42 mono||4096 px x 2160 px||42 fps||Mono||IMX255||
|Basler MED ace 12.3 MP 23 color||4096 px x 3000 px||23 fps||Color||IMX304||
|Basler MED ace 12.3 MP 23 mono||4096 px x 3000 px||23 fps||Mono||IMX304||
|Basler MED ace 12.3 MP 30 color||4096 px x 3000 px||30 fps||Color||IMX253||
|Basler MED ace 12.3 MP 30 mono||4096 px x 3000 px||30 fps||Mono||IMX253||
|Basler MED ace 20.0 MP 17 mono||5472 px x 3648 px||17 fps||Mono||IMX183||
|Basler MED ace 20.0 MP 17 color||5472 px x 3648 px||17 fps||Color||IMX183||
Can we help you?
Would you like to learn more about our quality management or our Basler cameras for Medical & Life Sciences?