Description
Strategiqual is a consulting and service firm at the crossroads of the worlds of medicine and medical devices. We offer an innovative and personalized approach to missions. Our main assets: expertise, dynamism and responsiveness. It is in this spirit that we offer high-end and recognized services in the fields of regulatory affairs, quality management, market access and training.
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Services
Medical devices
Development, clinical and regulatory
• Regulatory strategies, registrations and market access: Europe, USA and International
• Support in the development and preclinical and clinical strategy
• Operational implementation of market access: Technical File, PMA & 510k
• E-health specialist, DM software and validation of computerized systems
• Transition strategy to the new European MD and IVD regulations (MDR, IVDR)
Market Access Strategy and Reimbursement
• Evaluation of new innovative technologies
• Strategic analysis of market access and reimbursement in Europe
• Operational support in the realization of the request files for support for the France
• Training in reimbursement terms and knowledge of key players
• Interviews and meetings with decision-makers (HAS, MoH, KoLs, ect)
Quality Management & Inspection Authorities
• Creation and upgrade of the quality system: EN ISO 13485 and 21 CFR part 80
• Preparation Inspection Authority (ANSM, ANVISA) and notified body audits
• Control of advertising and promotion of medical devices
• Personalized regulatory, technical and clinical monitoring
• DMOS process and link transparency
Company's information
- Year of foundation
- 2012
- Company size
- PME < à 250 personnes
Target audience
- Healthcare
Strengths
- Assets 1
- Expertise
- Assets 2
- Dynamisme
- Assets 3
- Réactivité
Target audience
- All sizes companies
Consulting activities
- Data management consulting
- Strategy consulting
- Traceability consulting
- Management and organisation consulting
- Supply Chain Management consulting
- IT consulting