Medical Device covers a wide range of health or medical instruments used in the treatment, mitigation, diagnosis or prevention of a disease or abnormal physical condition. Classifications are based on their design complexity, their use characteristics, and their potential for harm if misused. Each country or region defines these categories in different ways.
Health authorities have heightened regulatory requirements to assess their safety, effectiveness, and quality before authorizing their sale in the markets.
PharmEng has extensive experiences dealing with the regulatory agencies. Whether the goal is to determine the substantial equivalence of your medical device, implement a quality management system that complies, or obtain approval for prior notification to markets, PharmEng will ensure your efforts comply with all regulatory requirements and standards around the world.
