To provide a series of fundamental principles that can be used to achieve compliance to In vitro Diagnostic Medical Device and Medical Device regulations using a clear, pragmatic approach that can be easily transferred into the Quality Management System of any IVD or Medical Device company.
A UK registered company based in the south east of England with broad expertise covering all aspects of in vitro diagnostics device regulatory affairs gained over more than 30 years’ practical and multi-functional experience working across the IVD industry.
We also offer assistance with all aspects of a quality management system compliant to the current ISO standards for IVD and medical devices.
Whatever the outcome of Brexit we are able to provide support to comply with Authorised Representative and Person Responsible for Regulatory Compliance responsibilities as required by the new IVD Regulation (2017/746/EU) and MD Regulation (2017/745/EU).
Are You Starting Up?
IVDeology have a history of supporting small and mid-size organisations including start-ups and are able to provide a suite of services from initiation of quality structure, global regulatory strategies, product delivery to market and post-market support.
Our aim is to support you from the first investigations of the IVD regulatory environment, giving clear, concise information based on industry experience through to providing ongoing mature regulatory and quality services.
We offer professional, friendly and flexible advice providing solutions to facilitate your company development and growth in confidence.