Medical Regulatory Consultancy

Our London based office is able to offer a professional and tailored portfolio of services in all matters relating to medical devices compliance/regulatory affairs for non-UK companies looking to trade in the United Kingdom as a result of the new legislative framework that came into effect following Brexit. 

In this regard our company is seeking to be the first-choice regulatory and logistics partner to all non-UK overseas companies looking for a trading presence in the UK.

In specific terms our company’s status as a UK based agency includes the following key services:

*UK Responsible Person (UKRP)

                -Regulatory pre-compliance checks for the UK market

                -Device registration for the UK market

                -Representation through a Quality Manager and regulatory consultants in the UK market

                -Information data for the manufacturer relating to any complaints and/or vigilance reports received in the UK market

                -Correspondence with the UK regulatory authorities as required

                -Retention of documentation and provision to the Medicines & Healthcare Products Regulatory Agency (MHRA) as required

*Management of complete Product Information File (PIF) including safety assessment and labelling review

*Arrangement of Inspection and Site Visits

*Logistics & Warehousing Services in the UK

Please contact the London office here for further information.

Fortuna Healthcare (Ireland) Ltd > Dublin Office

Our Dublin based office is able to offer a professional and tailored portfolio of services in all matters relating to medical devices compliance/regulatory affairs for non-EU companies looking to trade in the European Union as a result of the new legislative framework that came into effect following Brexit.

In this regard our company is seeking to be the first-choice regulatory and logistics partner to all non-EU overseas companies looking for a trading presence in the EU.

In specific terms our company’s status as a European based agency includes the following key services:

*EU Authorised Representative (EC REP)

                -Regulatory pre-compliance checks for the EU market

                -Device registration for the EU market

                -Representation through a Quality Manager and regulatory consultants in the EU market

                -Information data for the manufacturer relating to any complaints and/or vigilance reports received in the EU market

                -Correspondence with the EU regulatory authorities as required

                -Retention of documentation and provision to the EU product registration agency Eudamed as required

*Management of complete Product Information File (PIF) including safety assessment and labelling review

*Arrangement of Inspection and Site Visits

*Logistics & Warehousing Services in the EU

Please contact the Dublin office here for further information.