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Explore expert articles on medical devices and pharmaceuticals, covering regulatory updates, quality standards, compliance, innovation, and industry insights to help you stay informed.
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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