13/01/2025
Are you looking for a reliable partner to handle the assembly and kitting of your medical devices? Look no further than Clonallon, your trusted contract manufacturing provider with a state-of-the-art Class 7 Cleanroom. With a strong commitment to quality, compliance, and customer satisfaction, we specialize in helping medical device companies bring their innovations to life.
Why Choose Clonallon?
Certified Excellence
We hold ISO 13485 certification, ensuring robust quality management systems tailored to the stringent demands of the medical device industry.
Compliance with EU MDR 2017/745 means your products meet the highest regulatory standards for safety and performance, paving the way for seamless market access across Europe.
Strategic Location in Northern Ireland
Post-Brexit Advantage: Northern Ireland’s unique position under the Windsor Framework allows dual market access. This means your medical devices can move freely across both the EU and UK markets without customs checks or complex regulatory hurdles.
As part of the UK and benefiting from EU alignment for certain sectors, Northern Ireland offers unparalleled logistical and trade advantages for businesses navigating the complexities of Brexit.
Advanced Cleanroom Facilities
Our Class 7 Cleanroom provides a controlled environment designed for precision assembly and kitting of medical devices.
Strict particulate control ensures the highest levels of product integrity, essential for medical-grade production.
Cost-Efficient Manufacturing
Northern Ireland boasts a skilled workforce and competitive operating costs, enabling you to optimize production without compromising quality.
Seamless Partner for Global Growth
Our location and expertise make us the ideal partner for businesses aiming to expand into the EU, UK, or beyond, leveraging Northern Ireland’s robust infrastructure and trade connections.
Key Benefits of Partnering with Clonallon
Regulatory Confidence: Ensure your products meet rigorous international standards.
Market Reach: Effortless access to over 500 million customers across the EU and UK markets.
Time and Cost Savings: Focus on your core business while we handle the complexities of manufacturing and compliance.
Scalability and Flexibility: Whether it’s small-batch production or large-scale manufacturing, we adapt to your needs.
Let’s Build Your Success Story Together
At Clonallon, we understand the critical importance of precision, compliance, and timeliness in medical device manufacturing. By choosing us, you’re not just getting a manufacturer—you’re gaining a strategic partner who is as invested in your success as you are.
Contact Stephen Lennon on Stephen.lennon@clonallon.com today to discuss your requirements and discover how Clonallon can bring your vision to reality while ensuring a competitive edge in the evolving global market. Together, we’ll drive innovation and excellence in healthcare.
