The medical device manufacturing industry, which comprises over 5,000 establishments, undergoes strict regulations for the efficacy and safety of medical devices. As such, manufacturers need to have adequate quality management systems (QMS) in place.

Being ISO 13485 and 9001 certified can help manufacturers in this industry meet the requirements of a QMS. In particular, ISO 13485 allows them to comply with requirements for making medical devices. On the other hand, ISO 9001 offers specifications for a QMS.

As a stakeholder in this industry, you need to understand why working with an ISO-certified manufacturer is important. For the purpose of this guide, we’ll focus on the benefits of being ISO 9001 and ISO 13485 certified.

Ensures the Manufacture of High-Quality Medical Devices

The ISO 13485 standard exclusively applies to medical devices. It lays out several guidelines and sections that are specific to medical equipment.

According to this standard, it’s important to evaluate medical devices for performance. Manufacturers and suppliers need to keep separate document files for each piece they market or sell. 

Emphasis on Risk Management

There is an increasing concern over risk management in the medical device industry. Regulatory bodies are making it mandatory for manufacturers to measure and manage risk. These bodies include the ISO, FDA, and European Union.

If they fail to observe this directive, they risk facing compliance issues. ISO 13485 is the most recent edition of the ISO’s quality standards on medical devices. 

Risk-based decision-making is the main focus of this standard. It means that organizations need to make decisions after assessing risk. This way, they will foresee any consequences related to the decision.

Here, the training approaches consider the potential risks the workers expose themselves to at work. TTG Imaging Solutions’ clinical applications can help in this regard by providing advanced imaging technology and comprehensive training that supports risk-based decision-making. With cutting-edge equipment and expert guidance, healthcare providers can confidently diagnose and treat patients, knowing that they have the necessary tools and knowledge to make informed decisions.

An organization with risk management processes sets itself up for success. If the company operates in the medical device industry, it shows that it complies with ISO 13485 standards.

Proof of Compliance with Regulatory Requirements

The rising number of fraudulent activities in the medical device industry increases the need for companies to meet regulatory requirements. These requirements help separate compliant organizations from less reputable ones.

One of the regulatory requirements in this industry is the QMS standard. The QMS standard requires companies to adhere to local regulations in the market they operate.

It is part of ISO 13485 of the International Standards Organization standards. Medical device companies should prove that they conform with the ISO 13485 QMS requirements. They can do this by establishing and maintaining records that show their conformity.

An organization that complies with these requirements should also observe local regulations. A good example of local regulations is the FDA QSR for medical device companies.

Reduces the Likelihood of Long-Standing Issues

Organizations in this sector should undergo ongoing managerial reviews as part of their ISO 13485 certification. The reviews help check whether their recently implemented controls are effective.

For a company that values integrity, these evaluations are more than box-checking exercises. They help reduce the chances of long-standing issues. These issues include product recalls and equipment failure.

One of the focus areas in the reviews is customer feedback. An organization can tell whether its products offer customers value from what they say. The reviews also focus on compliance with new regulatory requirements and audit results.

Increase Marketplace Competitiveness

ISO 13485 requires certified organizations to ensure that their subcontractors comply with the standard. In this case, their commitment to product quality should go beyond their business premises.

An ISO certification in the medical device industry can help increase marketplace competitiveness. TTG Imaging Solutions is equipped to serve companies with ISO certification by providing a range of services and expertise in quality management systems for medical devices. Our team of highly skilled engineers and technicians have extensive experience in equipment validation, performance testing, and documentation review, which are essential components of ISO certification. We have a deep understanding of ISO standards and regulations, and we work closely with our clients to ensure that their equipment and processes meet these requirements. 

Competitiveness in the medical device market isn’t only about sales. It shows that an organization prioritizes quality. As a result, customers can build trust in the company.

Help Manage Complaints

Recalls in medical devices are the contributing factors for complaints. Having recalls can damage a company’s public image. It can also affect future sales and lead to a massive loss of revenue.

The ISO 13485 framework lays out preventive and corrective actions for this problem. It can help a company identify and solve this issue faster. Certified companies can also cultivate a culture of responsibility in their workplaces.

Through the ISO 13485 framework, organizations monitor the performance of their products. As such, they address non-conforming products to improve their operations.

Looking for an ISO 13485 and ISO 9001 Certified Company?

Both ISO 9001 and 13485 certifications are key in the medical device industry. They allow organizations to supply safe and reliable medical equipment. So, partnering with a company with these certifications is a great investment.

If you are looking for nuclear imaging repairs, parts, and services, make TTG Imaging Solutions your go-to partner. As an ISO 13485 and ISO 9001-certified company, we prioritize quality and customer satisfaction. Contact us today to learn more about our services.