Final delivery and validation of a medical device at a customer site is a significant achievement for all.
When control of the device is transferred to the customer, it represents the culmination of what may well be years of effort among thousands of people. Finally, patients have the opportunity to benefit from the tremendous investment of work and intellectual capital that must be involved.
However, it is rarely the end of the story.
Most devices, particularly large-scale capital equipment, require ongoing technical support and other expert services. The more complex the device, the more attention it typically requires. Support often continues throughout the device’s entire lifecycle.
There are, naturally, benefits to this arrangement for both the enterprise and the customer.
The customer enjoys the latest up-to-date service for their device, ensuring its presence can contribute fully to their ongoing efforts. The enterprise, meanwhile, has the opportunity to build on the customer relationship and ultimately make timely recommendations for future investments.
ISO 13485 helps establish a flourishing reciprocal relationship with its standards for rendering technical support and other services during the device lifetime. This ensures problems can be resolved quickly and accurately, minimizing downtime.
Ongoing Technical Support is a Long-Term Focus for Quality Compliance
As devices start to be deployed around the country or around the world, many organizations turn to authorized external agents to ensure continued support is rendered efficiently.
Regardless of whether support is managed by in-house staff, however, it is essential that all post-installation support be responsive, timely, and correct. If inaccurate information is provided by a support agent, the repercussions could be serious – for customer, end patient, and relationship.
With that in mind, medical device firms should strive to enact quality control mechanisms for their support processes proactively. As the final component of its complete quality management regime, ISO 13485 makes it possible to establish these controls more efficiently.
As a global standard, ISO 13485 also makes it far easier to scale up operations no matter where they may be based. This is ideal for organizations that wish to synthesize the cost-effectiveness of business process outsourcing with the unflagging standards of sophisticated in-house support.
Setting the Course for Compliance in Complex Post-Installation Activities
Technical support, repair, and servicing are all concerns that may be covered by the ISO 13485 standard when it refers to “related services.” Related services are not specified in great detail and may be defined and expanded upon according to the specific situation.
Where requirements in the standards refer to “medical devices,” the requirements apply equally to all related services that may be provided. To ensure success, internal controls must be carefully designed and rigorously maintained. Notably, the organization is furnished with broad latitude to determine how to structure and execute post-installation services.
Expertise from an external compliance partner can clarify and accelerate the process.
Organizations should expect to establish comprehensive knowledge resources before the initial deployment of any device requiring support. Likewise, policies and procedures must be in place for escalation from the front-line field agent to high-level technical experts as needed.
Enterprises must also be prepared to respond quickly and decisively to all customer complaints. These complaints may arise at any time in a product’s lifecycle and emerge from many different stakeholders. A strong response is imperative for maintaining rapport with the public and regulators.
Technosoft Innovations is the Trusted Partner for Comprehensive ISO 13485 Compliance
From beginning to end, appropriate quality compliance controls are crucial. However, few medical device enterprises have the internal expertise necessary for ISO 13485 and its complex requirements.
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