ISO 13485:2016 is an international standard for the Quality Management Systems of medical devices. It provides a framework for medical device companies to develop, implement, and maintain a Quality Management System (QMS) that meets regulatory requirements and enhances product quality.

ISO 13485:2016 covers all aspects of the medical device lifecycle, from design and development to production, distribution, and post-market surveillance. It emphasizes the need for risk management, traceability, and document control throughout the entire process.

The application of ISO 13485 can help medical device companies improve the safety and effectiveness of their products, enhance customer satisfaction, and achieve regulatory compliance.

Benefits of ISO 13485:2016 in the Medical Device Industry

ISO 13485:2016 is an international standard that specifies requirements for a quality management system (QMS) for medical device companies. Here are some benefits of implementing ISO 13485:2016 in the medical device industry:

Compliance with regulatory requirements

Compliance with ISO 13485:2016 demonstrates a medical device company's commitment to quality and compliance with regulatory requirements. This can help companies gain approval for their products in international markets.

Improved product quality

By implementing a QMS that adheres to ISO 13485:2016, medical device companies can improve their product quality. This can lead to fewer product defects, improved customer satisfaction, and reduced product liability risks.

Increased efficiency and productivity

ISO 13485:2016 necessitates medical device firms to create streamlined and productive methods to oversee quality, which may result in enhanced efficiency, diminished wastage, and better financial gains.

Enhanced customer satisfaction

Medical device companies can boost customer satisfaction by enhancing product quality and minimizing defects, which can eventually result in increased customer loyalty and a better standing in the industry.

Better risk management

ISO 13485:2016 requires medical device companies to establish a risk management process to identify and mitigate risks associated with their products. This can help companies reduce the risk of product recalls and lawsuits, and improve their overall risk management processes.

Continuous improvement

ISO 13485:2016 requires medical device companies to continuously monitor and improve their QMS. This can help companies stay up to date with industry best practices and improve their competitiveness in the market.

Why choose Intercert for your ISO 13485:2016 Medical Devices Quality Management System Certification?

Intercert is a reliable and proficient certification body that provides assistance to businesses seeking to achieve ISO 13485:2016 certification. Intercert offers several benefits to organizations pursuing certification.

With extensive experience and expertise in certifying organizations to the ISO 13485:2016 standard, Intercert has a team of over 125 certified auditors with the knowledge and skills necessary to assess and certify enterprises according to the standard.

Intercert utilizes a well-established and effective certification process that causes minimal disruption to organizations while ensuring quick and responsible certification. Additionally, to meet the unique needs and requirements of each organization, Intercert offers customized certification strategies. They collaborate with firms to develop a certification plan that is tailored to their specific needs.

Intercert is a globally recognized and respected certification body, offering Management System Certification Services approved by the reputable certification body Standard Council of Canada (SCC). Additionally, they provide accredited training by Exemplar Global to take advantage of the practical approach and benefits of certifications. Organizations certified by Intercert can demonstrate to their clients and relevant authorities that they have complied with the standards for ISO 13485:2016 certification.

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