Implementation of the mentioned standards into the production process allows choosing of the packing system that corresponds best with the certain medical device and providing stability and repeatability of the packing process. This is the warranty of maintaining of quality, safety and efficiency of the medical device within the declared service period.
It is also should be noted that GOST ISO 11607-1-2018 and GOST ISO 11607-2-2018 require implementation within the frames of the quality management system applicable at the manufacturer’s and complying with the requirements of GOST R ISO 9001-2015 Quality management systems. Requirements (ISO 9001:2015 «Quality management systems – Requirements») and/or GOST ISO 13485-2017 Medical devices. Quality management systems. Requirements for regulation.
These requirement of the standards is explained by the fact that maintaining of stability of packing processes is strictly associated with other production processes, such as incoming inspection and operational quality control, designing and development, maintaining of the enterprise infrastructure. Without proper control over these processes, it is perfectly impossible to comply with the requirements of standards GOST ISO 11607-1-2018 and GOST ISO 11607-2-2018.
Performance of validation of packing (packaging) process for the medical devices delivered in a sterile form is a mandatory procedure that provides market release of high-quality, safe and effective medical devices. Mistakes made during this procedure can lead to negative consequences with various harmful effect grade for the patients and/or the medical personnel. For that reason, we strictly recommend to perform validation in a full scope prior to releasing the medical devices to the market and to consider all the risks associated with packing discovered during the process of risk management.
If you have any questions regarding validation of packing process, our experts can develop quickly the required documents in strict accordance to the applicable standards and the requirements of the Federal Service for Surveillance in Healthcare. Our company’s experts get practical experience at production of medical devices with different risk classes. Contact us in any applicable way or submit an application for a back call.