Curvebeam Achieves ISO 13485:2016 & MDSAP certification

Curvebeam announced the company’s ISO 13485 certification has been updated to the latest revision of the standard. The company’s quality system is now certified to the ISO 13485:2016 standard, which represents the most recent revision of the widely recognized manufacturing quality standard issued by the international Organization for Standardization (ISO).

In addition to 13485:2016 requirements, this certification covers the requirements of the Therapeutic Goods Administration (TGA) of Australia; Brazil’s Agencia de Vigilancia Sanitaria (ANVISA); Health Canada; the U.S. Food and Drug Administration (FDA) under the Medical Device Single Audit Program (MDSAP).

“These latest accomplishments are the result of a significant effort by our entire quality, technical and operations teams,” said Ryan Conlon, Director of Quality and Regulatory Affairs for Curvebeam. “CurveBeam’s quality system lays a strong operational foundation for continuous innovation in orthopedic imaging.”

The ISO 13485 standard is specifically designed to certify medical device manufacturers and their key suppliers. The International Standard outlines requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.

Read more at curvebeam.com

Follow us on social media for the latest updates in B2B!

Image

Latest

university
The Employer University Alignment Journey with Kristen Fox, CEO of Business-Higher Education Forum
March 16, 2026

Across the U.S., the conversation about the value of a college degree is increasingly tied to one central question: Does higher education actually prepare students for the workforce? As artificial intelligence reshapes how work gets done and employers rethink the skills they need, universities are under growing pressure to ensure graduates leave not just…

Read More
private equity
How AI Is Transforming Private Equity Deal Evaluation and Portfolio Strategy
March 13, 2026

Artificial intelligence is rapidly transforming how organizations evaluate risk, analyze markets, and drive operational efficiency. In financial services alone, global AI spending is projected to surpass $97 billion by 2027, reflecting how deeply data-driven technologies are reshaping decision-making. For private equity firms—where hundreds of potential investments may be screened each year—the ability to analyze information…

Read More
The Tech-Enabled Hospital of the Future: Implications for Care Delivery
The Tech-Enabled Hospital of the Future: Implications for Care Delivery
March 12, 2026

Gone are the days when a hospital was simply a place where patients received care. Today’s hospitals are rapidly evolving into highly connected ecosystems powered by advanced technology, networked devices, and real-time data. The modern hospital is no longer confined to physical walls—it’s a dynamic digital environment where data flows seamlessly, AI supports clinical decisions,…

Read More
career
Stop Chasing Titles, Build a Career That Matters: A CAO’s Advice on Long-Term Success
March 11, 2026

Career advice in finance and accounting often centers around promotions, titles, and compensation. But in an era where professionals frequently change jobs every few years—the average American worker now stays in a role for less than four years—industries are facing growing talent shortages and reevaluating what long-term career success looks like. The question many…

Read More