Medical Device & Pharmaceutical Regulatory Consulting
Expert guidance for medical device and pharmaceutical companies navigating regulatory compliance across South Africa, the UK and EU.
Vesta Consulting
why choose us
We help medical device and pharmaceutical businesses navigate complex regulatory requirements across the UK, EU and South Africa.
From early product strategy through documentation review, market access and ongoing compliance planning, we provide practical guidance that helps organisations move forward with confidence.
Medical device & pharmaceutical regulatory specialist
UK, EU & South African regulatory knowledge
Practical, commercially focused advice
Support throughout the product lifecycle
Medical Device Services
Specialist Support for Medical Device Manufacturers
MHRA Registration
Registration and compliance support with the MHRA.
UKCA Marking
UKCA Marking support for medical devices in the UK market.
EU MDR Compliance
EU MDR Compliance strategy and implementation.
CE Marking
CE Marking guidance and support for your devices.
Technical Documentation
Technical file and documentation review and support.
Market Access Strategy
Market access strategy and planning support.
Additional SERVICES
Supporting regulated industries beyond medical devices
Pharmaceutical Regulatory Support
Support for pharmaceutical businesses navigating regulatory requirements, documentation, compliance planning 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, UKCA marking, and other compliance topics that may affect your business.
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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