Pharma Aggregation is a new trend in drug traceability, especially when industry experts have identified what a package-level serialization provides against counterfeiting and drug integrity. The USA’s Drug Supply Chain Security Act (DSCSA) has put a significant change in the power of medicines from the beginning....
Read More
Supply chain visibility becoming more important What is supply chain visibility? A common definition of supply chain visibility is the ability to track raw materials and components from original suppliers and manufacturers through the organization’s manufacturing facilities to customers. To gain benefits from this, such supply chain...
Read More
Currently, the UK is a participant in the European regulatory network for medical devices, but after the end of the transition period, this participation will also end. The Medicines and Healthcare products Regulatory Agency will take on the responsibilities for the UK market undertaken through...
Read More
The EU's Medical Device Regulation (MDR) was officially published on 5 May 2017 and came into force on 25 May 2017. The MDR will replace the EU’s current Medical Device Directive (93/42/EEC) and the EU’s Directive on active implantable medical devices (90/385/EEC). In this whitepaper, you...
Read More
Thanks to the research of the European Pharmaceutical Review, we are witnessing a wide examination of how the pharmaceutical supply chain is faring in the face of growing concerns about the impact of a sudden market disruption on the quality and availability of medicines. A...
Read More
In fact, this is jargon from the highly technical field of supply chain management. But what actually is included in the L1-L5 serialization solutions? Here is the simplest explanation with less jargon. Moreover, what makes SoftGroup the best choice for all your track and trace...
Read More![[Glossary] EU MDR and IVDR: The core terms you should know](https://cdn.shortpixel.ai/client/q_glossy,ret_img,w_900,h_400/https://www.softgroup.eu/wp-content/uploads/2020/10/Untitled-design-38.png)
The European Union (EU) is approaching its deadline to implement the Medical Device Regulation (EU MDR). As the transition period ends on May 26, 2020, a wider and clearer regulatory scope for medical devices is just around the corner. The EU MDR establishes requirements for manufacturers...
Read More
Last updated: 1st February 2021 Since the European medical device regulation is experiencing a major overhaul medical device manufacturers have to adjust their strategic approach to go through this change smoothly. The EU regulators take this action as an effective step towards enabling the Digitalization of...
Read More
Download the whitepaper now by filling the fields below and learn about the UDI requirements around the world. [contact-form-7 id="8530" title="Contact form - Aggregation Medical devices_UDI requirements"]...
Read More
Description The deadline for the introduction of serialization for medical devices and in vitro diagnostic devices is approaching. However, their implementation raises certain questions and challenges for manufacturers, importers, and authorized distributors. We are pleased to invite you to an online training seminar to introduce you to...
Read MoreBy continuing to use the site, you agree to the terms of our Privacy and Cookies Policy and the use of cookies. Privacy and Cookies Policy
The cookie settings on this website are set to "allow cookies" to give you the best browsing experience possible. If you continue to use this website without changing your cookie settings or you click "Accept" below then you are consenting to this.