Medical Device Regulatory Services
Expert medical device regulatory services for UK, EU and South African medical device compliance.
Explore Our Medical Device Regulatory Services
Whether you’re preparing to enter the South African market under SAHPRA, for UK market access or navigating EU MDR requirements, choose the service that best matches your current needs.
SA Regulatory Consulting
We help with:
✓ SAHPRA Licensing
✓ Gap Assessments
✓ ISO 13485 & QMS
✓ Ongoing Compliance
UK Regulatory Consulting
We help with:
✓ MHRA Registration
✓ UKCA Marking
✓ UK Responsible Person
✓ UK Market Access
EU Regulatory Consulting
We help with:
✓ EU MDR Strategy
✓ CE Marking Preparation
✓ Notified Body Readiness
✓ Technical Documentation
How we work
A straightforward process, from assessment to compliance
We follow a structured, step-by-step approach to help you understand your regulatory position, identify priorities, and move confidently towards market readiness.
01
Initial consultation
02
Information review
03
Gap Assessment
04
Action Plan
05
Delivery and Support
WHY CLIENTS CHOOSE VESTA
Clients choose Vesta Consulting because they want practical support that is focused on the real requirements of the job. We help turn regulatory expectations into a clear and manageable process.
Our clients value:
- Clear communication.
- Structured working methods.
- Practical recommendations.
- Professional regulatory judgment.
- Support that aligns with business timelines.
Frequently Asked Questions
Helpful information about our regulatory consulting services.
What do your medical device regulatory services include?
Vesta Consulting provides practical regulatory support across the UK, EU and South African markets. Depending on your needs, services can include regulatory gap assessments, device classification, market access strategy, technical documentation review, quality management support, licensing and registration, and preparation for ongoing compliance requirements.
Do you support the UK, EU and South African markets?
Can you support businesses operating in more than one market?
Yes. We can support businesses navigating regulatory requirements across multiple markets, including South Africa, the UK and EU. We can help identify the requirements that apply in each market and develop a structured approach to documentation, compliance and market access.
Can you help with medical device classification?
Yes. We can help assess the intended purpose and characteristics of your device and identify the applicable classification requirements for your target market. Classification can affect the regulatory pathway, documentation, conformity assessment and market access requirements.
What do I need to send before the first consultation?
Before a consultation, you should provide details about your device, intended use, device type, classification if known, target market and current regulatory status. Any existing technical documentation, quality management documents, licences or registration information, as well as relevant deadlines, can also help us assess your requirements more effectively.
What happens after the first consultation?
Vesta Consulting reviews the information provided and identifies the key requirements or gaps affecting your project. We then recommend a practical course of action, including the regulatory work required, documentation needed, priorities and potential next steps.
How long does a project take?
Project timelines vary depending on the device, target market, regulatory pathway and condition of your existing documentation.
