We use current regulatory intelligence, as well as our previous industry experience and expertise to provide independent advice and guidance on your regulatory strategy, quality systems or transition plans.
We are proud and active members of the British In Vitro Diagnostics Association (BIVDA) and are able to provide current regulatory and quality intelligence on global regulatory environments including EU, USA, Canada and rest of world.
UK RESPONSIBLE PERSON
Are you a non-UK IVD or Medical Device Manufacturer? If so have you considered the potential need for a UK Responsible Person in the event of a no deal Brexit from 31st October 2019?
Click here to view our blog to find out more information on this new requirement
We can provide a UK Responsible Person service and can act on your behalf for IVD device registration, communication with the UK competent authority (MHRA) and monitor post market feedback. Contact us for more information
Start-up, small and medium size IVD businesses
We aim to support start-up, small and medium size IVD businesses by having an ongoing relationship where we can pro-vide continuous quality and regulatory support for key activities like device design and development, device registration, notified body interactions, management reviews and post market activities, e.g. vigilance and recall activities.
We offer competitive rates and flexible offerings to allow start-ups and small business to obtain clear, pragmatic and constructive regulatory and quality advice in a tight budget.
For further information on our consultancy and quality compliance solutions please contact us here.