Medical Device & Pharmaceutical Regulatory Consulting
Practical medical device and pharmaceutical regulatory support across South Africa, the UK and EU.
Vesta Consulting
Why Choose Us
We help medical device and pharmaceutical businesses navigate regulatory requirements across South Africa, the UK and EU: including South Africa’s Medicines and Related Substances Act, EU MDR, and UK medical device regulations.
From early product strategy to documentation review, market access and ongoing compliance planning, we provide practical guidance that helps organisations move forward with confidence.
Medical device & pharmaceutical regulatory expertise
UK, EU & South African regulatory knowledge
Practical, commercially focused advice
Support throughout the product lifecycle
Medical Device Regulatory Consulting Services
What We Offer
SAHPRA Support
Support with SAHPRA licensing, registration and ongoing compliance requirements.
UK Market Access
Regulatory and compliance support for medical devices entering the UK market.
MHRA Registration
Support with MHRA registration and applicable UK medical device requirements.
EU MDR Compliance
EU MDR compliance strategy, documentation and market access support.
CE Marking
CE marking preparation and conformity assessment support for medical devices.
Technical Documentation
Technical documentation review, gap assessment and regulatory readiness support.
Additional SERVICES
Supporting regulated industries beyond medical devices
Pharmaceutical Regulatory Support
Support for pharmaceutical businesses navigating regulatory requirements, product documentation, GMP, submissions and market readiness.
Quality Management Guidance
Practical guidance on quality management systems, compliance strategy and regulatory processes that reduce risk and improve business readiness.
LATEST INSIGHTS
We publish updates and guidance on topics relevant to medical devices and regulatory change. This includes EU MDR, MHRA developments, SAHPRA requirements and other compliance topics that may affect your business.
EU MDR Compliance After CE Marking: What You Need to Know
For many medical device companies, getting a CE mark under the EU...
Medical Device Regulatory Compliance in South Africa: A Practical Guide for Manufacturers and Importers
South Africa's medical device regulatory landscape has undergone...
ISO 13485 Certification for Small UK Medical Device Importers and Distributors
ISO 13485 is the international quality management system standard...
EU MDR Compliance for Small Medical Device Companies: What You Need to Know
The EU Medical Device Regulation (MDR) 2017/745 has been fully...
Projects completed
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