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Ivdeology

Kent
  • IVDeology Ltd
  • Bryant House Bryant Road
  • Kent
  • ME2 3EW
  • 07713687921

Information

We are a small company based in the UK, with a broad background of expertise covering all aspects of IVD and Medical Device Regulatory Affairs gained over more than 30 years experience within the IVD industry.

We also offer assistance with the transition to ISO 13485:2016 and MDSAP including guidance and support for Audits and their preparation.

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).

Based in the surrounding area of the beautiful city of Rochester in Kent we are able to work with businesses all around the UK. We are a small business of like-minded, friendly professionals who are passionate about Regulatory affairs specifically within the in vitro diagnostic medical device industry.

We love talking about Regulatory Affairs and are enthusiastic in helping others understand how to navigate the IVD and medical device framework.

IVDeology Ltd are proud to be an active BIVDA associate member and regularly attend working party and seminars.


Our Services

IVD AND MEDICAL DEVICE REGULATIONS
We aim to offer simple, clear and simple advice on all aspects of regulatory affairs within the IVD and medical device sector, this includes:

IVD Directive (98/79/EC), IVD Regulation (2017/746/EU)
Quality Management Systems (ISO 13485:2016 / MDSAP)
Risk Management (ISO 14971:2012)
Global submission technical documentation including EU, FDA, TGA, Health Canada, RoW
Post Market Surveillance
Vigilance
Support prior to and during notified body and competent authority audits

We can help guide you through the principles and potential solutions to ensure compliance to European, USFDA and Rest of World IVD regulations including:

Product design and development framework
Technical File (STED) creation, remediation and maintenance
Risk Management (ISO 14971:2012)
Post Market Surveillance
Vigilance, non-conformance and CAPA
RoW submission frameworks
IVD/MD Labelling including UDI
Support for transitioning legacy products to the European IVDR and MDR and RoW
REACH

ARE YOU STARTING UP?
Here at IVDeology Ltd our expertise is to provide simple, clear advice and solutions for small and mid-sized companies on how to develop an IVD or medical device within a framework compliant to the UK, European and global Regulatory requirements.

The team has direct experience in providing regulatory and quality support developing a R&D facility into a commercial manufacturing business. This includes direct input in building a Quality Management System that is nimble and provides the flexibility required to support a business as it grows whilst maintaining full compliance at every stage.

We offer professional, friendly and flexible advice providing solutions to facilitate your company development and growth in confidence.


Our team members
Stuart Angell

Director