Medical Mind Technical Consulting

  • Project management, support and or complete outsourcing of product development projects including conformity assessment procedures and registration
  • R + D, optimization of manufacturing processes
  • Outsourcing of sub-processes
  • Design and application of national and international patents
  • Concept development and registration of Clean Room production
  • Process validation and verification
  • Biocompatibility tests
Medical Mind Regulatory Consulting

  • Clinical evaluations according to MEDDEV 2.7.1 and Annex X of the MDD 93/42/EEC as amended by 2007/47/EC for medical devices and combination products
  • Scientific literature and international safety data base research
  • Risk management according to ISO 14971
  • Project management and support of product development projects, national and international registrations and certifications: CE-Mark, 510K, etc
  • Compiling of technical documentation and submission of technical files
  • Direct Competent Authority and Notified Body contact and collaboration
  • Design, implementation and auditing of quality management systems and quality assurance activities according to ISO 9001, ISO 13485
Medical Mind Clinical Trials

  • Design, initiation and management of clinical trials
  • Clinical documentation - approval and management, protocol and CRF review / amendments
  • Design, clinical investigational plan development, approval, management and responsibility for phase 1,2, 3 and 4 clinical trials in accordance with Good Clinical Practice guidelines (GCP)
    and ISO 14155
  • Key opinion leader contact and clinical study team management
  • Scientific and regulatory training of the CRA´s
  • Monitoring
  • Liaison with sponsor, sites, data management, statistics and service providers
Medical Mind Business Consulting

  • Design and compilation of business cases
  • Medical evaluation of business cases and business models
  • Investor mediation and contact
Medical Mind Communication Services

  • Medical Science liaison
  • Scientific support of sales organizations and marketing campaigns
  • Direct customer liaison and support of key opinion leaders
  • Support of national and international patent applications
  • Design and concept development of packaging, brochures and other marketing materials
  • Scientific support, design and production of image films, 2D and 3D animations