It often takes years for an innovative medical device to go from concept to realization. For the device manufacturer, production and distribution are further steps in a long, complex journey. Installation at the customer site is the last phase before control of the device is transferred.
With its dedication to end-to-end excellence, ISO 13485 makes installation more efficient.
Installation and servicing of devices are coupled in this step in recognition of the fact different devices may have different requirements. The specific activities and expertise each device demands will depend strongly upon the product and customer environment.
The Installation Step as the Completion of Major Compliance Requirements
ISO 13485 recognizes the installation step as the fourth of five, and it is a major milestone due to the change it represents. Until this point, the medical device company has had complete control over the device – along with all the responsibility that entails.
With validation and verification at the site of use, the burden of responsibility shifts to the final customer. In some cases, this may be the end of the relationship. For the most part, however, the company will continue to provide ongoing maintenance and other services.
Knowing this, it is important to take due care with installation and servicing.
If a step is overlooked or done incorrectly, the device may not perform as expected. Through a lack of institutional knowledge on the customer’s part, this may have ramifications for patients that might not be known until a significant amount of time has elapsed.
In such a case, the manufacturer can still be held liable for complications that arise.
Luckily, ISO 13485 equips organizations with safeguards necessary to perform installation and execute this sensitive hand-off flawlessly. It does so with the diligence and attention to detail that has made it the globally-recognized gold standard in medical device quality management.
ISO 13485 Quality Management During Installation and Servicing
Documentation is the backbone of the ISO 13485 standard, as it allows organizations across the value chain to pinpoint and remediate exceptions quickly. Documentary requirements for device installation include its acceptance criteria and methods of final validation.
Although installation is typically performed directly by the medical device enterprise, authorized agents can also be used. If this is the case, the same quality of documentation that would be used internally must be supplied to those agents. They, in turn, must record final verification.
Complete visibility into all medical devices processes also includes recording and propagating adequate standards for sterile products. Sterile devices may require added measuring and monitoring equipment to verify final quality status before transfer.
Installation and servicing carry their own risks for communication and procedural breakdowns.
Introduction of the final customer into the process, potentially along with third-party partners, creates additional points of fault. It is up to the enterprise to maintain strict quality standards until the device’s performance can be validated.
Following installation, best practices in record retention are suggested to protect the enterprise’s interests going forward. It may be necessary to refer to installation or servicing records in the provision of ongoing services, such as regular maintenance and calibration. This accelerates those processes and makes errors less likely in the future.
Complete ISO 13485 Adherence Creates Value for Enterprises, Partners, and Customers
The value of ISO 13485 is perhaps never more evident than during installation and servicing. Through strict adherence, a company ensures that its customer can gain expected value from its devices from day one.
Technosoft Innovations helps medical device enterprises accelerate growth with ISO 13485-based processes, making a difference in markets around the world.
To know more: download our guide
For any additional questions, a proposal request or to book a free consultation, contact us