We’ve done it again! For the third consecutive year, Advena has successfully completed its ISO 13485 audit—achieving zero non-conformities (NCs)!
As a BSI-certified consultancy for ISO 13485:2016, Advena specialises in regulatory consulting, QMS expertise, and training for medical device and in vitro diagnostic (IVD) manufacturers. Our services also include UK Responsible Person (UKRP) services, EU regulatory compliance, quality management, and regulatory affairs.
The success of this audit is due to the dedication and expertise of our exceptional team. A special thank you goes to our QMS specialists, James Bradbury and Nirjit Nahal, whose hard work and resilience have been pivotal in ensuring our quality management system continues to meet rigorous ISO 13485 standards. Their efforts, alongside the commitment of everyone at Advena, were essential in achieving this milestone.
This achievement also aligns with the recognition we received as “Medical Device Regulatory Consultancy of the Year” by Medical Tech Outlook, further reinforcing our leadership and commitment to excellence in the field. It’s a proud moment for all of us at Advena, as it reinforces our role in providing the highest level of service to our clients.
At Advena, we understand that the medical device regulatory landscape is constantly evolving. That’s why we’re always ahead of the curve, providing the support our clients need to stay compliant and competitive in the market.
As we celebrate this achievement, we remain focused on providing the highest level of service, helping our clients navigate the complexities of regulatory requirements and ensuring they meet the highest standards in quality management.
Well done to the entire Advena team—here’s to another year of success and growth!
