from the Blog All You Need to Know About ISO 13485

In the medical devices industry, quality management processes cannot be negotiated, which is why the regulatory requirements are strict and why certification is vital. At BDK, we understand the importance of protecting the health of consumers which is why we have transitioned to the new ISO 13485:2016 standard.

What is ISO 13485?

ISO 13485:2016 is specifically designed for medical device manufacturers to ensure their quality management system enables and protects the quality and safety of finished products. Other organisations can also benefit from this certification such as: medical device designers, suppliers, importers, distributors and installers.

Although ISO 13485 is based on ISO 9001, incorporating the majority of the same requirements, it requires additional controls which include:.

  • Additional requirements in regards to documentation, validation, verification and identification of regulatory requirements
  • Increased focus on risk management
  • Coordination with global regulatory requirements

There is no compromise when it comes to defective devices, which is why you can trust us at BDK, providing reliable and innovative healthcare solutions for many years.