Regulatory Compliance Articles
Explore practical regulatory compliance articles covering medical devices, pharmaceuticals, and the latest industry requirements.
Latest Regulatory Compliance Articles
Vesta Consulting
Our articles cover medical device and pharmaceutical regulations across South Africa, the UK and EU, including SAHPRA requirements, MHRA registration, EU MDR, ISO 13485, medical device classification and market access.
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 Regulation (MDR, Regulation (EU) 2017/745) feels like the finish line. Under...
Medical Device Regulatory Compliance in South Africa: A Practical Guide for Manufacturers and Importers
South Africa's medical device regulatory landscape has undergone significant change over the past decade, and the pace of that change is accelerating. The...
ISO 13485 Certification for Small UK Medical Device Importers and Distributors
ISO 13485 is the international quality management system standard for medical devices. For UK importers and distributors, it sits at the centre of MHRA...
EU MDR Compliance for Small Medical Device Companies: What You Need to Know
The EU Medical Device Regulation (MDR) 2017/745 has been fully applicable since May 2021, with staggered transition deadlines running through 2028 for legacy...
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Frequently Asked Questions
Helpful information about our regulatory consulting services.
Can I contact Vesta Consulting about a topic covered in an article?
Yes. If an article raises questions about your regulatory requirements or compliance position, you can contact Vesta Consulting to discuss your specific device, product or market requirements and determine what regulatory support may be appropriate.
What regulatory topics do the articles cover?
Our articles explore practical regulatory topics such as SAHPRA licensing and registration, MHRA requirements, EU MDR compliance, ISO 13485, medical device classification, quality management systems, market access and regulatory developments affecting manufacturers and other regulated businesses such as importers and distributors.
Who writes Vesta Consulting’s regulatory articles?
Our articles are written by Tesha Hiralal, founder of Vesta Consulting, drawing on her experience in regulatory affairs and as a former SAHPRA Medicines Control Officer and Inspector.
How often do you publish new regulatory compliance articles?
We publish new articles regularly, covering regulatory developments, industry updates and practical guidance across the South African, UK and EU medical device and pharmaceutical markets.
