IVDeology Ltd

medical devices

About

IVDeology Ltd is a UK-based consultancy focused on quality and regulatory compliance for the in-vitro diagnostics (IVD) industry. Founded in January 2018 and located at the Maidstone Innovation Centre in Kent, the company has a team of approximately 9 employees, including directors and quality consultants. The company provides essential services to start-ups, distributors, and multinational manufacturers in the IVD sector. Their offerings include regulatory support to navigate complex compliance landscapes, UK Responsible Person (UKRP) services for post-Brexit market access, and assistance with quality management systems (QMS) to ensure adherence to regulatory standards. IVDeology is dedicated to patient and consumer safety, helping clients ensure their diagnostic products meet necessary regulations for safe and effective market placement in the UK and Europe.

Technologies

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Keywords

persons responsible for regulatory compliance in vitro diagnositics quality management system post market surveillance iso 14971 risk management regulatory affairs medical device ce mark vigilance authorised representative technical file mdsap ivd regulation ukrp iso 13485 prrc ukca medical equipment manufacturing qms development ivdr transition post-market surveillance regulatory gap analysis ivd compliance ivd technical files ukca marking ukrp services risk assessment product registration medical devices

Location

Maidstone, England, United Kingdom

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