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About Us
At Infomed Consulting, we help medical device companies with their regulatory needs.
We provide expertise in fields ranging from engineering to quality and regulations. We are dedicated in helping companies in the medical device industry establish their market presence through effective compliance.
We take pride in being your trusted partner in a complex regulatory landscape.
Our Why
Results
Global Reach
to empower businesses in the dynamic medical device industry to be successful in getting their devices to the market.
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​ we support a diverse range of clients from medtech startups to small to medium-sized companies and government agencies across the globe.
from the EU to the US, Africa, and beyond, we provide strategic guidance to help you expand your business and access new regions
What we do
As your number one trusted advisor and source of knowledge, Infomed Consulting offers a comprehensive suite of services, including:
01
Quality Audits: Ensuring compliance and identifying areas for improvement.
03
Regulatory Submissions & Registrations: Guiding you through the intricate process of preparing and submitting regulatory dossiers to relevant authorities for market approval.
02
Regulatory Gap Assessments: Pinpointing discrepancies and developing strategies to bridge them.
04
Market Access Strategies: Guiding your products through the regulatory pathways to successful market entry.
05
Training: Empowering your team at all organisational levels with essential regulatory and quality knowledge.
07
Workflow Development: Streamlining operations for enhanced efficiency and compliance.
06
QMS Development & Improvement: Designing and refining Quality Management System processes for optimal performance.
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Regulatory Affairs and Quality Assurance Outsourcing: Our outsourcing service allows you to focus on growing your business while we serve as your trusted, full-service RA/QA partner.