We are thrilled to share some exciting news with you.
We are now ISO 13485 certified for the scope of Regulatory consultancy and support services to the medical device industry!
Receiving the ISO 13485:2016 certification reinforces Asphalion’s commitment to maintaining the highest standards in quality management and our relentless pursuit of continuous improvement. ISO 13485:2016 is an international standard that specifies requirements for a quality management system (QMS) for organizations involved in the design, development, production, installation, and servicing of medical devices and related services.
What does this mean for our clients?
Strengthen our commitment to quality: Asphalion, which has always operated under high levels of quality demands, now holds the ISO 13485 certification, which is the leading quality standard in the MedTech world.
Compliance with Regulatory Requirements: Compliance with ISO 13485 demonstrates a commitment to meeting regulatory requirements in the medical device industry.
Global Market Access: ISO 13485 is recognized internationally, our clients around the world can rely on the certainty of our work.
Improved Efficiency and Effectiveness: ISO 13485 encourages us to streamline our processes and improve efficiency. By implementing best practices outlined in the standard, we can reduce errors increasing the quality of our services.
For further details or to initiate a consultation, do not hesitate to contact us: medtech@asphalion.com
