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ISO 13485:2016 International standard in Quality Management of Medical Device Certificate

The fundamental philosophy used to build our company is through a process, not a person. Every technician employed by Modern Dental Laboratory must attend our technician school (located within our laboratory). These beginning and advanced courses are the backbone of the lab because this is where the patient-centric culture is instilled and adherence to very specific manufacturing processes it taught..

These specific manufacturing regulations are administered by the ISO 13485:2016, ISO 9001:2015 and EN 46002. By meticulously abiding by these stringent regulations, we are able to continually produce consistent products.

Certification for medical device manufacturers

ISO 13485:2016 is a quality system standard designed specifically for medical device companies. The ISO 13485 standard has many of the same requirements as ISO 9001. However, there are additional requirements for process control, design control, retention of records, accountability, traceability and more.

ISO 13485 is the most commonly chosen path for medical device companies to meet the quality system requirements in Europe, Canada, Japan, Australia and other countries. Although implementing ISO 13485 is voluntary for manufacturers selling in Europe, most companies opt to apply this standard to demonstrate compliance with the Directives. In Canada, ISO 13485:2016 is mandatory for Class II, III and IV medical device manufacturers (with additional requirements imposed under Canadian law). Compliance with Japans Ministerial Ordinance #169 is quite similar to ISO 13485 with additional requirements imposed under Japan law..

What is ISO 13485:2016?

The ISO 13485:2016 certificate is the international standard in quality management for medical device manufacturing, and is the most rigid global standard in manufacturing, exceeding even those of the FDA. Obtaining this level of certification is the key to eliminate variability in our processes so that our dentists always get consistent output.

Advantages of ISO 13485 certification:

As we mentioned, ISO 13485 certification is not mandatory in most markets. Here is how your company can benefit from ISO 13485:2016 certification:

  • Compliance with European standards offers straightforward access to the Japanese, Australian and New Zealand markets
  • Other countries around the world also recognize ISO 13485 as a means of meeting their quality requirements
  • ISO 13485 is a globally recognized standard and having this certification will increase the credibility of your company with potential customers.

With over 25 local offices worldwide, Emergo Group has helped hundreds of medical device and IVD manufacturers implement quality systems that meet the ISO 13485 standard. Our team of experienced ISO 13485 consultants have implemented numerous quality management systems for companies manufacturing a wide range of medical devices.

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Backed by the support of our team of engineers and other experts associated with different industries, we provide quality certifications for individual projects as well as corporate houses. We offer reliable quality certification services to organizations looking for solutions to the management of systems for:

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Address: Punjabi Bagh,                 Delhi
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E-mail: certification.delhi@gmail.com

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