anteris diagnostics | In Vitro Diagnostic Product Consulting

anteris diagnostics means support for in vitro diagnostic (IVD) medical device product development, and registration in EU and US.

We offer support in the following areas:

> Effective project management, tying together your internal organization, development partners, suppliers, Notified Bodies, and regulatory agencies.
> We provide the development resources providing you with flexibility in a changing environment or ramp-up phase.
> With our diverse background (IVD, medical devices, combination products, and biopharmaceuticals) we are uniquely positioned to help you navigate the challenges of highly regulated industries.
> We support your implementation of, or transition to ISO 13485:2016.
> We support your transition from IVDD 98/79/EC to IVDR 2017/746.
> We establish technical documentation under your established processes.
> We develop registration strategies for your new product, or for expanding to new markets.
> We audit and manage your suppliers, and establish seamless processes tying into your quality system.
> Tools – audit ready technical documentation is easily managed by appropriate software tools.

We are looking forward to discussing any opportunity to support your development and registration project.

Company’s Keywords:

quality management, regulatory strategy & compliance, in vitro diagnostics, risk management, ivdr 2017746