In the rapidly growing market for medical products, regulatory barriers for the manufacturers of such products are also on the rise. Legal requirements for cooperation between manufacturers and suppliers regarding quality management mean high expenditures, as companies select suppliers and evaluate their quality assurance processes.
Makers of medical products who must procure the components for their products from external sources also bear the responsibility for these externally manufactured parts, not just in development and production but during the entire product lifecycle. For vision-based systems, this also applies to cameras.
How can a manufacturer of medical products ensure that its component providers reliably meet the high standards in medical technology? Certification according to ISO 13485:2016 offers this reliability. In our White Paper , Basler product manager Peter Behringer describes the requirements of the medical device standard for the quality management systems of manufacturers and suppliers, and explains why a successful certification results in clear benefits for both sides.
Basler has been certified according to ISO 13485:2016 for the development, production, sale and service of digital cameras since 2018. The MED ace product line is the first series-produced camera on the market that is being produced, sold and maintained across its lifecycle according to ISO 13485:2016. If you have questions or need support, our Sales Team is pleased to help you any time.
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