ISO 13485 Audits: Key Mistakes to Avoid for Seamless Compliance Preparing for ISO 13485 audits can be a high-pressure task for medical device manufacturers. Ensuring compliance with ISO 13485 standards and the Medical Device Regulation (MDR) is essential to secure market access, maintain regulatory credibility, and protect patient safety. The stakes couldn’t be higher: A […]
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Understanding Quality Challenges in the Medical Device Industry in Oman As Oman strengthens its regulatory environment for healthcare, quality challenges in the medical device industry are becoming increasingly complex. Manufacturers in Oman must adapt to evolving international standards while aligning with Ministry of Health (MOH Oman) requirements. At Operon Strategist, we specialize in helping manufacturers
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ISO Certification in Oman: Ensuring Quality in Medical Devices Oman’s healthcare sector is growing rapidly, creating demand for safe and reliable medical devices. To meet international standards, manufacturers are adopting ISO 13485 certification, the globally recognized quality management system (QMS) that ensures product safety, regulatory compliance, and consistent quality. For Omani manufacturers, ISO 13485 is
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