Case Study: C2DX, Inc. achieves MDSAP certification and impresses auditors with Greenlight Guru's MDQMS

C2DX, Inc. Impresses Auditors and Achieves MDSAP Certification After Implementing Medical Device QMS(MDQMS)

C2DX, Inc., a medical device company that acquired the STIC Intra-Compartmental Pressure Monitor System, needed to establish a quality-first culture, complete the acquisition while maintaining Stryker-level customer experience, and quickly implement an electronic quality management system. To meet those needs they selected Greenlight Guru’s medical device QMS (MDQMS) as their purpose-built eQMS.

By implementing Greenlight Guru, C2DX, Inc. went live with an audit-ready MDQMS in under 30 days, streamlining document control, training, design transfer to contract manufacturers, and post-market workflows. The result: rapid FDA approval (within 30 days), successful MDSAP and ISO 13485 audits, a paperless audit experience that impressed auditors, and a scalable quality foundation to support future growth.

C2DX, Inc.

Kevin McLeod

Chief Executive Officer