Pratiksha

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 […]

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