Most people never think twice about the syringe used during a blood test or the catheter placed before surgery. But behind every one of those devices is a very deliberate decision about what it is actually made from. The materials used in medical devices don’t just give a product its physical form, they determine whether …
Common Medical Device Materials and Their Importance in Healthcare Read More »
Drug device combination products keep growing within Europe healthcare systems. These are integrated therapeutic products that contain a pharmaceutical substance and a medical device. They’re found in lots of everyday therapies, including prefilled syringes, auto injectors, pen injectors, inhalers and drug-eluting implants. They aid in accurate and convenient delivery of medication. Even so, building and …
ISO 14971 Risk Control for Drug-Device Combination Products Read More »
The Injectable Drug-Device Combination market holds a significant and growing presence within the European medical device landscape, driven by high expectations for quality, safety, and performance. When designing a pen injector intended for use in the European Union, adherence to a rigorous and complex regulatory framework is not optional, it is a fundamental requirement. From …
Designing Pen Injector to Meet EU Quality Requirements Read More »
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 …
Threshold Analysis: A Critical Regulatory Document Requiring Expertise Read More »
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 …
Benefits of ISO 13485 Certification Consultants for Medical Devices Read More »
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, …
EU MDR Clinical Evaluation Requirements for Device Safety Read More »
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. …
Common Pitfalls in Combination Product Regulations & How to Avoid Them Read More »
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 …
How to Get CE Marking For Medical Devices in Europe Read More »
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 …
How to Get Notified Body Opinion for Drug-Device Combination Products Read More »
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 …
