Camera-based Products in Medical & Life Sciences – What Are the Benefits of a ISO 13485:2016-Certified Supplier?
In the rapidly growing market for medical products, the reliability of devices and systems is of particular importance with regard to safety for patients and users. Thus, the regulatory hurdles are high and the legal requirements for the manufacturers of such products are strict. Many manufacturers purchase components from external suppliers and are particularly dependent on their reliability due to their extensive product responsibility. The new ISO 13485:2016 certification ensures this reliability within the framework of quality assurance and thus offers advantages both for manufacturers and their suppliers.
In our White Paper, Peter Behringer, Product Manager for Medical & Life Sciences at Basler, describes the requirements of the medical device standard for cooperation in quality management between manufacturers and suppliers and how these can best be met.
The following topics are covered in detail:
- ISO 13485: Medical products standard
- ISO 13485:2016 – What specific concerns does it introduce for manufacturers that use cameras in their products?
- Requirements for suppliers with the new ISO 13485:2016
- What are the advantages of Basler AG's ISO 13485:2016 certification?
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