Ursus Major Consultancy Utrecht

Experts in Medical Device EU Regulatory

Projectmanagement

 

Research and Development - Hard- and (embedded) software - Verification and validation - Phase transition - Change control - Intellectual property - Information management

Troubleshooting

 

Stuctured analysis - Second opinion -Conflict resolution - Mediation - Intervention - Redesign - Legal representation -  Stakeholder oriented pragmatic approach

Consultancy

 

Medical Device Directive - Harmonized Standards - Risk management - Quality assurance - Conformity assessment - Testing - Clinical investigation - Vigilance - Post market surveillance

(c) 2014 Ursus Major