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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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iso 13485 certification

Benefits of Hiring ISO 13485 Certification Consultants for Medical Devices (QMS)

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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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eu mdr

Clinical Evaluation Requirements Under EU MDR: Best Practices for Device Safety

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The European Union Medical Device Regulation (EU MDR) has changed the way medical device manufacturers prove their products are safe and effective. One of the most important parts of MDR compliance is a clinical evaluation that underpins all efforts to make very sure medical devices comply with strict safety laws in Europe.  In this blog, …

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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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How to Get Notified Body Opinion Report for Drug Device Combination Products in Europe

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The regulation and market approval of Drug Device Combination Products (DDCPs) in Europe is a specialized and intricate process due to the combined nature of medicinal and device components. Manufacturers are required to seek a Notified Body Opinion (NBOp), which is a component of the conformity assessment for the EU Medical Device Regulation (MDR)2017/745, when …

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quality management systems

Types of quality management systems

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QMS is a set of interconnected elements (Quality Policy, Procedures, Manual, Work Instruction, Records) that directs and controls the organization in consistently meeting customer requirements and enhancing their satisfaction. What is quality management systems? The quality Management System is a framework organizations use to ensure consistency in delivering products, services, and processes that satisfy or …

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