Why Is ISO 13485 Training Critical to Building a Career in Medical Devices?

The medical device industry is booming. The U.S. medical device manufacturing market was valued at 176.7 billion USD in 2020 and is anticipated to exhibit a compound annual growth rate (CAGR) of 5.0% by 2028. A growing population and technological advances have led to an increased demand for medical devices.

Medical devices need to be safe and effective to help patients. They also need to be cost-effective and manufacturable for the company. Medical devices are inherently risky, which means we have more regulations because there’s more likelihood of risk to patient safety. Their design requires specific knowledge that is not found in other industries.

Every medical device set to hit the market has to go through many checks and audits before it even leaves the manufacturing unit. A risk-based approach is used to identify, evaluate, and mitigate risks associated with a product or project.

Built specifically for this industry, the ISO 13485:2016 standard is an important tool to keep every team member on track when designing and releasing a new medical device.

Being trained in ISO 13485 gives medical device manufacturers the support to design a quality management system that enables consistency and effectiveness throughout each stage of the product life cycle.

The apparent advantage of the ISO 13485 training courses is that it provides an understanding of how the product will be built and manufactured, streamlining every process from design to the final disposal of the product. However, there are other ample benefits of getting trained, making it critical for your career in medical device development.

More Control Over Quality with Systematic Operations

Operational inefficiencies can hinder the entire process of manufacturing. Without a system to comprehend them and produce consequent action for improvements, quality will always be impacted.

The ISO 13485 training enables manufacturers to establish norms that pave the way for effective communication to pinpoint the product deficiencies along with systemic techniques and methods to counter them.

It promotes a standardized way of manufacturing with an organized structure in all processes. The addition of constant Management Reviews brings the focus on data provision to monitor progress and formulate the subsequent path if defects are identified, both in terms of product development and quality requirements.

With the quality management system, the manufacturers are always in control, guaranteeing that the products developed meet the quality and safety standards that fit both the patients and users.

Less Time to Market with Quality Assessment

Organization in manufacturing processes has a direct impact on the speed of development. With continuous monitoring of processes and systems, any defect or deficiency that could lengthen the development time is detected and rectified early on.

From administration to purchasing, all departments involved benefit from an organizational culture that stimulates excellence. Quality Management System training emphasizes quality in every stage of manufacturing, thus ensuring the devices are produced at a faster rate.

More Value with Less Waste

Another positive impact of quality systems training is on the waste produced during manufacturing medical devices. Overproduction, excessive waiting on process completion, surplus inventory, multiple defects, and unregulated scraps are aspects of the production cycle that can be avoided with the implementation of the ISO standards.

Constant supervision of the standard ensures the identification and resolution of problems that could result in a wastage of time, effort, and resources. With fewer failures to battle, consumers remain happy with the quality of the products. By targeting to achieve process excellence, you invest less in production, including labor, and profits run higher.

Wider Scope for Business Growth

The ISO 13485 training brings the scope of collaborating with larger organizations. Their preference often reflects an inclination towards ISO-certified suppliers as they meet exceptional quality and service standards.

If you have implemented the standard, you will offer the same reliability and quality that medical devices need to have across the globe. Such standardization in production makes your product the perfect fit for exports.

With a stringent adherence to a risk-based approach to minimize them as well as the legal, contractual, and regulatory requirements for medical devices, you will have the opportunity to make your company a priority when large companies need subcontractors and broaden your business practices.

Get all the benefits of being ISO certified with Prime Path Medtech™’s Quality System Training. From describing objectives to identifying device requirements and comprehending their real-world application, you and your team will be able to recognize the common elements found in the global QMS requirements.