Complex production processes seem impossible without software in production. However, proof must be established ensuring a risk-minimized operation within QM-relevant processes (ISO 13485).We support you in identifying and evaluating the software correctly as well as in representing the processes within your quality management system appropriately.Our experts are happy to provide their help and advice for all validation activities.
The more complex the device, the higher the requirements of a modern production; the more networked the production, the higher the share of software. Keep control of the increasing complexity with validating your software.
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ISO 13485:2016 defines the requirements for a quality management system in which a company has to prove that it is in the position to provide medical devices and related services that fulfill the customers’ needs and comply with applicable regulations.The GAMP guideline introduced the risk-based approach to the validation of computer-assisted systems in 2005. GAMP 5 today is THE standard guideline. ISO / TR 80002: 2017 applies to any software used in device design, testing, component acceptance, manufacturing, labeling, packaging, distribution, and complaint handling or to automate any other aspect of a medical device quality system as described in ISO 13485.The AAMI TIR36: 2007 is a best practice guide for the “Validation of software for regulated processes”.