Passing MDSAP Audit & Getting FDA Approval Just Weeks After Implementing Medical Device Success Platform
September 7, 2022
Experienced medical device professionals can agree that investing in quality early on and putting it at the forefront of building a company can give you a competitive advantage.
Whether it be an early-stage company or one with a device already on the market, taking a quality-first approach by establishing a robust electronic Quality Management System (eQMS) will set the foundation for scalable growth and propel your company towards success.
After acquiring a product [from Stryker], the experienced team of medical device professionals at Critical Care Diagnostics (C2DX), Inc. knew they had to ensure 4 things to be successful:
- Establish a quality-first approach to the company’s culture
- Complete the acquisition and continue delivering a high-quality device
- Quickly implement an electronic quality management system that could act as a foundation for both their initial needs and future growth
- Provide the same customer experience customers had grown to expect from Stryker
Deliver a Gold Standard Product For Monitoring Compartmental Pressure
After previously starting and operating two medical devices companies, Kevin McLeod, CEO of C2DX, Inc., came across the opportunity to acquire a product used for diagnosing Compartment Syndrome – known as the STIC Intra-Compartmental Pressure Monitor System. This device has been used for over 30 years and has clinical data supporting why it is the Gold Standard tool used by physicians to promptly diagnose and monitor compartmental pressure in patients.