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© 2026 cohaga AG · All Rights Reserved · St. Gallen, Switzerland · Imprint745,041 companies indexed · Last updated: today
DirectoryBusiness & Technical ServicesTechnical Consulting & EngineeringGrand-LancyBeyond Conception GmbH
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Beyond Conception GmbH

Summary

About the company

The core activity of Beyond Conception is providing consulting and management services in the field of regulatory compliance for medical devices and combination products (MDCP). This includes, in particular: Regulatory consulting and strategy development for MDCP; Design, planning and implementation of compliance strategies for EU-MDR, including Article 117 Notified Body Opinions; Packaging design and engineering; IT project management, data management and security; Anti-counterfeiting measures. The company supports global organizations in implementing regulatory requirements and helps them bring their products to market safely and in compliance.

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Products & services

Industry:Technical Consulting & Engineering
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Regulatory Strategy and Submission Management
Pre-Submission Strategy, Combination Product Classification, Marketing Authorization Applications, Global harmonization planning for FDA-, EMA- and other global pathways.
Project Management & Program Leadership
Integrated program leadership, critical path & milestone management, cross-functional vendor coordination, design control & documentation governance for combination-product development.
Risk Management and Clinical Evaluation
Integrated risk lifecycle management, targeted clinical strategy, regulatory alignment and iterative compliance support with CEP/CER for standalone medical devices.
Human Factors Engineering & Design Validation
Use-related risk analysis, formative usability studies, summative human factors validation, instructions for use development and label comprehension studies.
Packaging Development and Testing
Primary packaging selection, secondary packaging design, sterile barrier validation, labeling & serialization compliance for prefilled syringes, autoinjectors and biologics.
Design History File (DHF) Creation
DHF architecture & organization, EU MDR technical documentation, living documentation systems, gap remediation for legacy products and design transfer documentation.
Design Verification
Design verification planning, biocompatibility & sterilization validation, drug-device interface testing for prefilled syringes, autoinjectors and infusion pumps.
QMS Remediation and Integration
FDA 21 CFR Part 4 CGMP integration, ISO 13485 implementation, post-market surveillance & vigilance, notified body readiness and remediation of non-conformities.
Companion Diagnostics Development
CDx regulatory strategy, clinical validation planning, analytical performance verification, manufacturing readiness and labeling & claims strategy for companion diagnostics.
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Location

Esplanade de Pont-Rouge 5
1212 Grand-Lancy

At a glance

Legal form
Limited Liability Company
UID
CHE-442.793.354
Founded
2013 · 13 years
Last commercial register change
August 4, 2026
Employees
1 to 10

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