Performing authorised representative duties in the UK for medical device companies.

In compliance with FDA 21 CFR 807.40, we provide regulatory agent services (US Agent) for medical device companies.

An EU-authorised representative is a natural or legal person expressly designated by a manufacturer located outside the EEA (including the EU and EFTA) as an EU-Representative, i.e. an EU-authorised representative, also known as an EU-representative. This natural or legal person can perform on behalf of a manufacturer outside the EEA the specific duties required of the manufacturer by the relevant EU directives and laws.

National system regulations and standards training, TPMP training for e-cigarettes, risk management training, software lifecycle training, usability training, clinical GCP training, process validation training, computerised software validation training, national registration regulations training, clinical evaluation and customised training for medical device companies, cybersecurity training, and long term regulatory consultancy services.

Medical device process validation training.

Topical training on the full life cycle of medical device software.

Medical Device ISO 14971 Risk Management Training Services.

Coaching for the QSR 820 system in the United States, BGMP system in Brazil, JGMP system in Japan, KGMP system in South Korea, UKCA QMS system in the United Kingdom, and FDA factory inspection in the United States; as well as coaching for medical device systems in other countries.