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our service offering
Explore our comprehensive services.
Your Gateway to Global Medical Device Markets
We specialise in helping companies tap into the high-growth potential of the African market. Our expertise extends to major jurisdictions around the globe. We provide the intelligence and on-the-ground support you need to achieve market authorisation efficiently and compliantly.
Navigating the complexities of global medical device regulations can be a major challenge. We simplify this process, serving as your strategic partner to successfully bring your products to new markets worldwide.
Regulatory Strategy & Intelligence
Get a clear, customized roadmap for your market entry. We analyze your product and target jurisdictions to provide strategic guidance on regulatory pathways, classification, and key requirements. Our intelligence services keep you updated on evolving regulations to ensure continuous compliance.
In-country Representation
For markets that require a local presence, we act as your official in-country representative. We handle critical regulatory communications, post-market surveillance, and incident reporting, protecting your company and your market position. We currently provide representation for the following jurisdictions: - New Zealand Sponsor:We serve as your mandatory local sponsor, managing WAND database notifications and all official correspondence with Medsafe. - South African Authorized Representative: We act as your appointed representative to SAHPRA, managing your medical device establishment license and ensuring ongoing compliance in the region.
