Medical Device

threshold analysis

Threshold Analysis: A Critical Regulatory Document That Demands Professional Expertise

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Complying with the European Medical Device Market is no longer an option – it’s a strategic imperative. Manufacturers are faced with highly regulated environments, changing standards and high-quality demands in order to compete. However ISO 13485 certification is one of the most important standards in terms of quality management system for medical devices, and under the guidance of …

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combination product regulations

Common Pitfalls in Combination Product Regulations and How to Avoid Them

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In an ever-evolving world of pharmaceutical and medical technology innovation, the combination products are changing the way in which patients are being treated. From prefilled syringes, nasal sprays, inhalers, ophthalmic, MDI/DPI, pen injectors, auto injectors to drug-eluting stents, these combination products offer potential life-saving therapies — but they also carry with them unique regulatory hurdles. …

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combination product regulations

How to Get CE Marking For Medical Devices in Europe

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Gaining access to the European market with your medical device is a cause for celebration, but comes with regulatory mandates. One of the most critical is gaining ce marking for medical devices, which will prove that your product complies with the health and safety and performance requirements specified by the European Union (EU). Without this …

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