GLOSSARY

ISO 13485 Standards

Compliance with the ISO 13485 standards is often seen as a first step to establishing the regulatory compliance required to sell medical devices in the European Economic Area, but adopting the standard can also help med device companies comply with 21 CFR Part 820 and gain access to other global markets.

The International Standards Organization (ISO) first published ISO 13485 in 1996 and later produced a revised version known as ISO 13485:2016. The latest document institutes an international standard for the establishment and maintenance of quality management systems at medical device companies that is tailored to the industry's quality system expectations and regulatory requirements. Under the newly revised European Union Medical Device Regulation (EU MDR), companies must demonstrate compliance with ISO 13485 before they may sell medical devices in Europe.

Benefits Of Compliance With ISO 13485 Standards

Compliance with the latest ISO 13485 standards provides full-circle benefits for medical device manufacturers. Here are just a few reasons why your medical device company will benefit from establishing compliance with this global quality standard for medical device companies:

Access Global Markets - The International trend in medical device compliance is that global regulators are moving toward harmonized regulations that will apply across markets. At the forefront of that harmonization is ISO, the organization which studies global markets and creates international standards according to their requirements. Compliance with ISO 13485 is required for medical device companies that wish to sell in Europe, Canada, and other markets around the world.
Decrease Organizational Risk - The quality processes required by ISO 13485 standards can significantly decrease the risk associated with operating your medical device company. The ISO 13485 mandate is designed to ensure that your company builds products that are both safe and effective for the end user. Building a device that is effective for its intended purpose is crucial to the success of your product, and the safety measures mandated through ISO 13485 compliance ensure that your device will not harm the end user, helping to limit recalls and CAPA issues throughout the product lifecycle.
Increase Organizational Efficiency - ISO 13485 requires medical device companies to standardize their manufacturing processes by ensuring consistency in suppliers, materials, manufacturing processes, procedures, and even training personnel. Adherence to these requirements helps ensure that medical device companies can consistently produce quality products at a profit.

Standards Conformity VS Regulatory Compliance - Is There A Difference?

ISO 13485 is a voluntary standard - firms that conform to the standard can benefit from certain perks, such as being able to sell medical devices in the European Union, but compliance with ISO 13485 is ultimately a voluntary decision that medical device companies make.

On the other hand, medical device companies that sell their products in the United States must comply with the FDA's 21 CFR Part 820, a legal mandate for medical device quality systems. If your medical device company is in the United States, an FDA inspection that results in observed violations or a warning letter could lead to civil prosecution for failure to comply with the appropriate regulations.

Learn more about the difference between standards and regulations here.

Greenlight Guru Facilitates Compliance With ISO 13485 Standards

Greenlight Guru’s Quality Management Software platform has been specially tailored for the medical device industry to facilitate compliance with ISO 13485:2016 and help med-tech companies reduce time-to-market for their products. A paperless repository of all your quality procedures and compliance documentation ensures that both ISO and FDA audits finish smoothly and successfully.