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VISION
Infomed Consulting was established in 2020, emerging from a clear need:​
to provide affordable and accessible regulatory affairs and quality assurance expertise to businesses in the dynamic medical device industry
We work with manufacturers, distributors, and other interested parties, helping them navigate complex regulatory landscapes and achieve market access efficiently.
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Its vision is to create an environment where innovation is promoted while still achieving medical compliance and safety. This combination is mutually beneficial for customers, who develop such devices, and their end users.
MISSION
Our mission is simple:
to support organisations in getting their devices to the market.
Infomed Consulting is committed to delivering expert knowledge to its customers. The main mission is to enable companies and organisations across the globe to turn their ideas into market-ready products.
Infomed Consulting identifies the importance of improving the healthcare systems. To this end, Infomed Consulting considers itself a key element in alleviating the challenges associated with delivering market-ready solutions.
WHY US
Our expertise spans from local South African regulations to key global regulatory systems, including ISO 13485, EU MDR, and MDSAP (covering Australia, Brazil, Canada, US, Japan).
we support a diverse range of clients from medtech startups to small to medium-sized companies and government agencies
We do this by partnering with our clients to develop their regulatory strategy, build their systems in compliance with applicable quality standards, get audit-ready and perform internal audits, and train personnel on quality systems.
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.
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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.