For manufacturers, missing supplier information is the main cause of lost sales and product recalls. Medical device companies will face increased risk...
Increased Personal Protective Equipment Production: What About Compliance?
Since the COVID-19 pandemic hit, there has been an unprecedented demand for personal protective equipment (PPE). The use of PPE by medical professiona...
Upcoming Product Compliance Deadlines You Can’t Miss
Product compliance legislation is always changing, but one thing remains the same — companies need to comply with looming deadlines. While there is al...
Contact Lens Solution Caught In Between REACH Regulation, EU Medical Device Regulation Conflicts
Triggered by issues with conflicting regulations for contact lens solution, a Registration, Evaluation, Authorisation and Restriction of Chemicals (RE...
Changes to EU MDR See Deadline Extended 12 Months
Following a formal request from MedTech Europe, the European Union (EU) Medical Device Regulation (MDR) deadline has officially been changed. The 12-m...
5 Steps to Transforming Your Supply Chain to Build Emergency Medical Equipment
COVID-19 has put strain on the medical system, and tools for combating the virus are running scarce. Manufacturers are being asked to begin producing ...
Ask the Experts: Understanding Changes From the EU Medical Device Regulation
Our regulatory subject matter experts help a range of stakeholders solve compelling regulatory challenges associated with supply chain data management...
The Impacts of COVID-19 on the Regulatory Landscape
As the COVID-19 pandemic continues to unfold, companies are finding it difficult to make informed decisions about their products, supply chains and re...
How Brexit Will Impact the EU Medical Device Regulation
After the UK formally left the European Union (EU) on January 31, 2020, a number of questions remained regarding the impact on businesses selling prod...
Proposed Update to EU MDR Deadline
The COVID-19 (coronavirus) outbreak has put a halt to many aspects of everyday life around the world. As infection rates and the death toll mount, peo...