Quality Management System (QMS) and ISO 13485
Medical device manufacturers who want to sell their devices on the European market are required to comply with ISO 13485. This is an internationally recognized standard for quality...
Cost of obtaining the EUMDR 745/2017
Obtaining the EU MDR Medical Device regulation is considered a new revolution that will change how medical devices are traded on the European market. The EUMDR 745 2017 replaces the...
Selling Medical Devices in Europe
Now that Europe has new Medical Device Regulations that are governing the process of placing medical devices on the European market, it is important to analyze the step-by-step processes....
Post Market Surveillance and Vigilance in the European Market
Entering the European market requires a couple of steps that manufacturers need to consider for an effective launch of new products. One of the steps, the end, manufacturers need to work on...
Innovative Technologies in the European Dental market
The dental industry is rapidly evolving with the introduction of new technologies and advancements. One such technology that has revolutionized the dental industry is 3D printing. Many...
Requirements relating to notified bodies in the European market
Manufacturers who want to place their products on the European market should fulfill some legal requirements. Depending on the class risk of the product, manufacturers should employ an...
Medical Equipment Shortages: EU Market Disruption Prevention Measures
In a post-pandemic scenario characterized by one of the worst economic recessions in recent times, the European economy has made strides to help them recover after the devastating impact of...
Data Protection in the European Pharmaceutical Industry
Data protection in the pharmaceutical industry refers to the safeguarding of sensitive information related to patients, clinical trials, and research and development activities from...
Germany: The Biggest European Pharmaceutical Market
Germany is undoubtedly one of the most prominent life science nations in the world. It is home to Europe's largest pharmaceutical market, a number of industry leaders, a growing biotech...
Pharmaceutical Trends and developments to watch in 2023
During the COVID-19 period, the pharmaceutical industry was characterized by fast-paced research that continuously put the entire healthcare sector on a rise. Different technologies and...
