OMD – Quality Management System Certification for Medical Devices

OMD is a Conformity Assessment Body’s accreditation to provide a consistent and reliable certification, according to the ABNT NBR ISO 13485 standard, to allow national authorities an opportunity to improve their health systems through the use of certification OMD accredited from manufacturing companies without losing valuable access to medical devices.

More than 50% of medical devices are considered low-risk. Many low-risk medical devices are safer than less-regulated consumer products. Enabling healthcare professionals to access a broader range of medical devices provides a much-needed benefit to a country’s healthcare system. The OMD accredited certification, by the ABNT NBR ISO 13485 standard, is suggested to regulate medium to high-risk medical devices.

OMD Accredited Certification within a regulatory framework grants healthcare professionals access to medical devices manufactured in another country, which is fundamental to all healthcare systems. In fact, most countries import more medical devices than they export. Every country must sensibly regulate access to medical devices to protect its citizens from unsafe devices.

OMD certification addresses medical device quality management systems and regulatory requirements. The ABNT NBR ISO 13485 standard is based on the ABNT NBR ISO 9001 Quality Management System standard. However, it focuses less on business performance and more on risk management.

Although an audit carried out following the ABNT NBR ISO 13485 standard for OMD certification may include an examination of the design and development of a product, it is not a product certification standard, as it is not directly linked to the specification of the manufactured products.

OMD certification ensures that manufacturers consistently produce medical devices that meet regulatory requirements and are designed and manufactured to be safe for their intended use.

Source: The IAF Initiative for Accredited Certification to ISO 13485 – Medical Devices. https://iaf.nu/iaf_system/uploads/documents/IAF_ISO_13485_0512.pdf