Plan and implement your ISO: 13485:2016 transition with the help of experienced regulatory experts.

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.

How we can help

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.

  • ISO 13485 Gap Assessment: Our quality system experts perform a rigorous gap assessment and analysis looking specifically for gaps between ISO 13485:2003 and ISO 13485:2016. The results of this assessment are clearly detailed in an actionable list of recommended next steps.

  • Remediation/Revision Plan & Implementation: Following a thorough gap assessment, our regulatory specialists develop and, if needed, implement a plan to remediate and revise the QMS to comply with the new standard. All actions are implemented to align with a risk-based approach.

  • ISO 13485:2016 Pre-certification Audits & Training: If necessary, especially for those choosing to upgrade their quality systems internally, our regulatory experts can conduct pre-certification audits prior to the actual certification audit performed by your Notified Body or Registrar. This offers the opportunity to have a confidential initial assessment separate from those conducted by certification authorities.

Looming deadlines require action now

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.

The benefits of working with The FDA Group 

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.

Contact The FDA Group today to learn more about our ISO 13485:2016 Remediation & Staff Augmentation services.