Enabling you to identify and mitigate the intrinsic risk in your operations, supply chains and business processes.
Evaluating how your products and services meet and exceed quality, safety, sustainability and performance standards.
Validating the specifications, value and safety of your raw materials, products and assets.
25, 2016, ISO 13485:2016 focuses on quality management systems and is
recognised and used as a framework by the medical device industry, regulators programs
including the Medical Device Single Audit Program (MDSAP). Transition to
the 2016 version must be implemented by the February 28, 2019 transition
The standard provides manufacturers, designers, and suppliers to the medical device industry with an updated framework necessary to demonstrate compliance to regulatory requirements and mitigate risks to stakeholders. It places more emphasis on risk-based thinking and decision-making while it also offers stronger intra-operability between the clauses and requirements.
Perhaps most importantly, it focuses on ensuring consistent quality, product safety and the sustainable success of your products or services, using competent and efficient quality management systems to support them. Persistent pressures from global competition demand that organisations continually improve your products, services, and business processes to remain competitive
Key elements of the ISO 13485:2016 standard include:
Partner with us and gain the confidence of knowing you have a solid Quality Management System in place for medical devices.
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