ISO 13485:2016 (QMS)

ISO 13485:2016 (QMS)

ISO 13485:2016 - Quality Management System (QMS)

TUV SA provides professional certification and evaluation services for ISO 13485:2016, the internationally accepted standard for Quality Management Systems in the medical device sector. Organizations engaged in the design, development, manufacturing, installation, and maintenance of medical devices must adhere to this standard.

According to the Saudi Food and Drug Authority (SFDA), the U.S. FDA, and the European Union’s Medical Device Regulation (MDR), ISO 13485:2016 certification from TUV SA shows that you are dedicated to safety, compliance, and reliable product quality.

Benefits

Quality Management System (QMS)

A structured framework for creating and sustaining a QMS that is adapted to the particular safety, performance, and regulatory requirements of the medical device industry is offered by ISO 13485:2016.

Regulatory Compliance

FDA Quality System Regulation (QSR) compliance, CE Marking, and SFDA licensing are just a few of the important regulatory requirements that can be met with TUV SA certification. It is a fundamental prerequisite for businesses looking to get permission to join and function in international healthcare markets.

Product Safety and Risk Management

The standard promotes active risk management and the decrease of adverse events while enforcing strong design, production, and post-market control procedures that put patient safety first.

Consistency and Quality

In order to create medical devices that are safer, more dependable, and compliant, ISO 13485:2016 encourages the adoption of standardized procedures, documentation, and quality controls.

Customer Satisfaction

Businesses that have earned TUV SA’s ISO 13485 certification demonstrate their commitment to quality control and product integrity, which boosts consumer confidence and fosters trust with regulators, distributors, and healthcare providers.

Improved Efficiency

By putting the standard into practice, inefficiencies can be found, waste can be cut, and overall productivity can be raised, which improves resource use and lowers operating expenses.

Competitive Advantage

ISO 13485:2016 certification is a crucial differentiator in the expanding and cutthroat healthcare industry, boosting credibility and facilitating partnerships, procurement, and tender success.

Global Market Access

International acceptance of ISO 13485 and alignment of your company with international quality and safety standards through TUV SA certification open doors to important international markets.

Continuous Improvement

In order to foster a culture of continuous innovation and improvement within your company, the standard calls for frequent internal audits, management reviews, remedial actions, and monitoring activities.

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