IVD & Medical Device Regulations

Specialists in In Vitro Diagnostics (IVD) and Medical Device Quality and Regulatory Consultancy, Training and Compliance Support.

Expert consultancy advice for Medical Device Companies

Consultancy

Regulatory and quality consultancy, expert analysis and focused solutions for the IVD industry from start-up to mature organisations

Training and mentoring for Medical Device Companies

Training & Mentoring

Providing tailor-made training solutions across all aspects of IVD regulatory and quality functions. Also offering mentoring services to support development of in-house quality and regulatory professionals

Compliance Support for Medical Device Companies

Compliance Support

Delivery of functional quality and regulatory services including Authorised Representative services under current European requirements and preparing to address the potential requirement for a UK Authorised Representative dependant on Brexit outcomes

Our mission:

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 Manage-ment System of any IVD or Medical Device company.

Are you ready for the IVD Regulation?

The IVD Regulation (2017/746/EU) was published in May 2017 and lays down new requirements for IVD Manufacturers, Authorised Representative, Importers and Distributors. The Regulation has a 5 year transition period and will result in the biggest change to the regulation of IVDs since the implementation of the IVD Directive 98/79/EC.

The Regulation will impact all Economic Operators who manufacture or distribute IVDs within the EU. IVDEOLOGY LTD can help your business navigate the new requirements of the IVD Regulation and can support you as you place product on mar-ket.

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We support start-up, micro and small size businesses

IVDeology Ltd 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. Contact us for more information on how we can help your business be ready for IVD compliance.

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IVDEOLOGY IVDR App Download

IVDEOLOGY IVDR App

Free to download now

Download our IVDR App, providing an article by article reference tool for the EU IVD Regulation 2017/746/EU. The App is available to download for free from the Apple App store and Google Play Store.

IVDEOLOGY IVDR Manual Download

IVDEOLOGY IVDR Manual

£10 per copy +P&P

We can provide a printed copy of the IVD Regulation in a handy ring bound A5 size book. This includes a table of contents to allow easy reference to all the articles, chapters and Annex. To order your copy contact us.


Meet Our Team - Click Here

The Team at IVDeology

We are proud to be BIVDA Associate Members

IVDeology Ltd Proud To Be BIVDA Associate Members