When does a company’s responsibility for its medical devices end?
In a certain sense, the answer is never. That is, companies continue to be judged based on the quality of their devices as long as they are in use. Customers, including patients who may be undergoing lifelong care, will continually reappraise a brand based on device performance.
From the manufacturing perspective, there is a clearer – but still challenging – answer.
A medical device company’s responsibility to maintain excellence in quality does not diminish until final verification and validation on the customer side. For capital equipment, this typically refers to installation.
With that in mind, the distribution and storage of devices are both topics covered under the ISO 13485 quality management standard. The standard helps enterprises recognize and safeguard against the fact that lossage can occur while product batches are in transit or even in the warehouse.
Distribution and Storage as Key Steps in Quality Management
The logistics surrounding medical devices are complex – perhaps moreso than any other commercial product. Devices must be handled to ensure they maintain expected properties throughout the supply chain. Likewise, it must be possible to trace their movements exactly.
The ISO 13485 standard is built around the idea that the medical device manufacturer is the principal agent in all things related to product quality. This means distribution and storage remain under its purview, even though many related tasks are usually carried out by others on a contract basis.
The selection of an able logistics partner is therefore of crucial concern.
When logistics is outsourced, the partner must be willing and able to maintain the enterprise’s full quality standards for as long as medical devices are in transit. Clear expectations must be set at the beginning and maintained based on ISO 13485 recommendations.
This is one area where a third-party organization with expertise in ISO standards can be helpful, serving as a mediator to develop a selection process and build the framework of collaboration with the logistics organization.
ISO 13485 Recommendations for Storage and Distribution
Some period of storage is likely inevitable before a finished product is delivered to an end user. While only some products have a limited shelf life, all products must be identified, handled, packaged, stored, and protected adequately through final delivery.
ISO refers to this under the general term preservation of property.
Documented procedures must be in place to manage products and maintain traceability – if necessary, worldwide. When products require specialized storage conditions, these conditions must be controlled, monitored, and recorded – thus identifying non-conformance quickly.
There are many situations in which medical devices require special measuring and monitoring equipment to verify continued quality compliance across the supply chain. ISO 13485 establishes guidelines for managing this equipment and the data it provides. This gives operators greater insight and ability to recognize when the equipment itself, not the environment, is at issue.
The ISO 13485 standard also recognizes medical devices are not the only “property” an organization may come in contact with. Indeed, there may be times when the organization has control of customer assets – including equipment, records, and even confidential intellectual property.
Since such situations introduce additional compliance requirements, it is no surprise that they are also covered under the ISO 13485 umbrella. Enterprises must be prepared to practice end-to-end awareness of all resources that bear on the overall quality mission.
The experts at Technosoft Innovations help medical devices manufacturers exercise the clarity and control they need to reach sterling ISO 13485 adherence. This raises quality and streamlines tough regulatory compliance challenges worldwide.
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