Regulate Group OÜ

Regulate Group OÜ is rated 3 out of 5 in the category medical devices. Read and write reviews about 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.