ISO 13485:2016 is the first major revision of the world’s most popular medical device quality management standard since 2003. Currently, medical device companies have until March 2019 to update their current ISO 13485 certificate to this most recent version.
The transition to ISO 13485:2016 likely requires significant change for many affected companies, especially given the greater focus on risk management, supplier controls, and complaint handling. However, with the help of a quality system expert who has helped multiple companies with this transition, it can be a straightforward process.
Our large staff of quality system experts provide comprehensive on-site ISO 13485:2016 transition services to ensure your organization is prepared for a successful certification.
With certification deadlines quickly approaching, regulatory compliance experts are in high demand. It’s imperative to schedule quality system remediation and revision as soon as possible to avoid delays or lapses in certification.
We recognize the challenges of developing and managing an effective quality system under the watchful eye of regulators. Our quality system resourcing professionals draw on years of experience and highly specialized skills to ensure objective, accurate, and actionable recommendations are made each step of the way.
Our proprietary talent selection process brings together a diverse array of skill sets, experience, and expertise to offer a truly unique opportunity for companies interested in receiving personal and professional attention.