Medical device Manufacturing - Operon Strategist

CE Mark for Intraocular Lenses: Step-by-Step Guide under EU MDR 2017/745

Intraocular Lenses (IOLs) are one of the most widely used implantable ophthalmic devices designed to replace the natural lens of the eye, typically after cataract surgery. To market these devices in the European Union — including Germany, a major hub for ophthalmic innovations — manufacturers must obtain the CE Mark for Intraocular Lenses in compliance […]

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ISO 13485 Certification for Medical Device Manufacturers in Germany

Medical device Manufacturing / Shubham

Germany is one of the largest and most advanced medical device markets in Europe, recognized for its strong regulatory framework, precision manufacturing, and quality-driven culture. To maintain market trust and ensure compliance with European regulations, ISO 13485 Certification has become an essential requirement for medical device manufacturers operating in Germany. This international quality management system

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Disposable Medical Device Manufacturing and Regulatory Approvals in Germany

Overview of Disposable Medical Device Manufacturing Germany is one of the most advanced and quality-focused healthcare markets in Europe. The demand for disposable medical devices is rising significantly due to infection control measures, patient safety protocols, an aging population, and increasing outpatient procedures. These single-use products—including syringes, catheters, IV sets, diagnostic swabs, and surgical gowns—minimize

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