Medical device companies doing business in the European Union (EU) may have circled May 26, 2021, in red on their calendars — but any company treating...
Why EU MDR Compliance Is Important for Global Manufacturers
For manufacturers, missing supplier information is the main cause of lost sales and product recalls. Medical device companies will face increased risk...
The Regulatory Landscape for Medical Devices
Due to their impact on human life, medical devices are highly regulated. Not only that, but the list of products in scope of medical device regulation...
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...