Regulate Group OÜ

Regulate© is a global consultancy firm providing regulatory consultancy and market entry services for Medical Device and In Vitro Diagnostic Medical Device (IVDD) manufacturers and their approved suppliers.

Regulate© has highly skilled Consultants in the areas of Regulatory Affairs, Development, Clinical Research and Medical Affairs.

Regulate© Consultancy Services include:

– Technical File and Design Dossier Development for CE Marking.
– STED Preparation.
– MDD 93/42/EEC, IVDD 98/79/EEC and AIMD 90/385/EEC.
– European Medical Device and IVDD Regulation GAP Assessment Services.
– FDA Quality System Regulation 21 CFR Part 820, ISO 13485:2016 and ISO 9001:2015.
– Regulatory Assessment of device changes.
– Risk Management, Human Factors and Usability.
– Unique Device Identification (UDI), GS1 Barcoding and GTIN Management Services.
– Clinical Investigations and Evaluations.
– Medical Affairs Expertise.
– CAD, Verification and Validation.
– Authorised Representative Service for outside of EU Medical Device Manufacturers.
– Project Management.
– CAPA Assistance.
– Medical Device Cybersecurity.
– Regulatory Systems for a Design History File.
– FDA GUDID Upload Assistance.
– Technical File Linguistic Translation.
– Subject Matter Experts for Hire.

Company’s Keywords:

authorised representative, regulatory affairs, udi, sted documentation