ISO 13485 Software - Quality Management System for Medical Devices

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ISO 13485 software adapts the ISO 9001 process model of Plan, Do, Check, Act designed for regulatory compliance and is more prescriptive by requiring a more demanding quality management system and documentation.
In today’s competitive business environment operating internationally or expanding locally, companies with an ISO 13485 certification communicate a quality commitment to both customers and regulators. It allows increasing access to more markets worldwide, provides a mechanism on how to review processes across your organization for continuous improvement, and can increase efficiency, cut costs and improve your supply chain performance.

In 2016, ISO 13485 was updated to reflect general concerns, the need for clarity within the standard and to serve as a harmonized QMS model to be used by national and regulatory bodies. ISO 13485:2016 has increased focus on product realization planning, training “competency,” integration of QMS software, harmonization across other country laws, etc. and integrates “risk” throughout the QMS including supplier controls, change management, and product lifecycle for risk-based decision-making.

An internationally accepted standard by the FDA and other countries, ISO 13485:2016 is increasingly being required or at least beneficial in supporting regulations around the world, including Health Canada Canadian Medical Device Regulations CMDCAS program. In the absence of another update specific to the EU, CEN/TR 17223:2018 was introduced to provide the guidance on the relationship between EN ISO 13485:2016 and the new MDR (EU 2017/745) and IVDR (EU 2017/746) regulations which entered into force in May 2018. In addition, ISO 13485:2016 has become the backbone of the MDSAP (Medical Device Single Audit Program) with its integration in 2019.