Medical device compliance, performance

Edison, New Jersey – Oriel STAT A MATRIX officials announce eight new certification programs covering the most critical compliance and performance issues in the medical device industry.

Medical device manufacturers are experiencing an industry-transforming level of demand and growth, but rapid innovation, complex products, and global supply chains are negatively impacting product quality and performance. In response, U.S. FDA and global regulators are increasing compliance requirements, scrutiny, and enforcement. To compete in this challenging environment, medical device companies must work harder than ever to improve quality, lower risk, and maintain compliance.  

"Savvy medical device professionals know that these industry changes create career opportunities. They seek out skills-focused certification programs to position themselves to meet key industry needs," said Alan Marash, CEO of Oriel STAT A MATRIX.

Oriel STAT A MATRIX offers such professionals eight specialized certification tracks. Each track addresses a specific compliance or performance need in medical device manufacturing. Earning a certification demonstrates to both employers and external regulators that a person has subject matter expertise and a commitment to professional development. 

"Medical device manufacturers desperately need problem solvers. They want more employees with the ability to take ownership of activities critical to the FDA and other regulators, such as product design, manufacturing, supplier management, and postmarket surveillance," said Lisa L. Michels, global practice head for medical devices and life sciences at Oriel STAT A MATRIX.

Oriel STAT A MATRIX's certification programs were designed to empower medical device professionals by giving them both subject matter knowledge and problem-solving skills. 

There are eight certification options from which to choose:

• Design control practitioner
• Management control practitioner
• Production and process controls practitioner
• Supplier management practitioner
• Quality system practitioner
• Corrective and preventive action leader
• Applied statistics and process performance leader
• Performance-based auditing leader

Source: Oriel STAT A MATRIX