Strategiqual

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

Contact

Name and firstname
Pascale Cousin  
Email address
pascale.cousin@strategiqual.com  

Company's information

Year of foundation
2012  
Company size
PME < à 250 personnes  

Strengths

Assets 1
Expertise  
Assets 2
Dynamisme  
Assets 3
Réactivité  

Target audience

Healthcare
 

Target audience

All sizes companies
 

Consulting activities

Data management consulting
 
Strategy consulting
 
Traceability consulting
 
Management and organisation consulting
 
Supply Chain Management consulting
 
IT consulting
 

About the partner

STRATEGIQUAL

Member since 4/26/22

Location

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