DQS is a globally recognised certification and notified body with over 20 years of experience in the medical devices industry. Our personalised and agile approach ensures that manufacturers, from startups to multinational corporations, receive expert guidance in achieving compliance with international and local regulations. With a single point of contact for all certification needs, we simplify the process and help businesses navigate complex regulatory landscapes, unlocking the full potential of their medical devices.

Our accredited certifications enable medical device manufacturers to expand into new markets and enhance the quality, safety, and compliance of their products and processes. We offer certification solutions such as CE Marking (MDR (EU) 2017/745), MDSAP (Medical Device Single Audit Program), ISO 13485, ISO 15378, TCP III, and more. Among these, ISO 13485 is a globally recognised standard for quality management systems (QMS) tailored to the medical device industry. It integrates risk management, traceability, and regulatory compliance to ensure that medical devices are safe, effective, and aligned with both international standards and local requirements.

For manufacturers in South Africa and across Africa, ISO 13485 certification demonstrates a commitment to rigorous quality management, operational efficiency, and regulatory compliance. By adopting this standard, businesses can streamline processes, improve product development cycles, and gain a competitive edge in the global market. Compliance with ISO 13485 also facilitates regulatory approvals from bodies such as SAHPRA, the MCC, the EU MDR, and the FDA, allowing manufacturers to expand their reach and export medical devices worldwide.

DQS is your trusted partner in achieving certification excellence. Our expertise in medical device compliance, active participation in industry standards and regulatory committees, and global network of over 200 assessors ensure that you receive comprehensive support throughout the certification process. Let us help you meet regulatory requirements with confidence and unlock new opportunities in the medical device industry.