FDA and Internationally Regulated Medical Devices

Medical Device Training Overview

Today’s medical device and diagnostic companies face increasing complexity, which has generated the growth of numerous specialties. Not only must marketing be able to think globally and act locally, but so must regulatory, quality, and manufacturing. Regulatory harmonization has resulted in requirements that are less prescriptive but more demanding in their interpretation and implementation.

Expertise and Global Research
The STAT-A-MATRIX FDA-Regulated Industry staff consists of former FDA investigators and other experts from the medical device and pharmaceutical industry. Our consultants average more than 23 years of industrial experience; none have less than 15 years of experience. Several STAT-A-MATRIX consultants have participated in the development of guidance documents and guidelines issued by FDA and the European Comission; others have participated in the development of international standards. With more than 100 consultants based around the world, we can respond immediately to our clients varied business and regulatory needs.

STAT-A-MATRIX can help. We have been a resource for over four decades and have the technical proficiencies that enable medical device and diagnostic companies to focus on their core competencies. Learn more about our experience with U.S. FDA and International Regulations.

Companies that perform well in FDA and other audit inspections embrace practices that go beyond merely complying with regulations. They develop and maintain quality management systems where regulatory compliance is a logical outcome of an organizational culture that integrates quality and regulatory requirements with business imperatives. STAT-A-MATRIX is here to help.

STAT-A-MATRIX provides subject matter experts and experienced practitioners who target individual needs within small and large organizations.

We provide on-site audits, training, coaching and facilitation in reviewing or implementing design controls, risk management, new product introduction, process efficiencies, gap analysis, and more.

We specialize in all aspects of quality systems, technical services, and regulatory consulting, as well as training support for medical device and diagnostics organizations regulated by the FDA and selling in worldwide markets.

We offer assistance in complying with ISO standards, medical device directives, CE marking, FDA good manufacturing practices, and other national and international guidelines.

Our goal is to transfer knowledge and the tools you need to succeed.

A Road Map for Medical Device Training for Professionals

If you are part of a medical device organization regulated by the FDA, we will help you understand FDA’s Medical Device Quality System Regulation (QSR), whether you are just entering the medical device industry or need to update your training.

Over the years, STAT-A-MATRIX (SAM) has developed a proven road map to help you meet your medical device training needs for management system compliance and continuous improvement. SAM’s unique and comprehensive approach focuses on establishing and implementing management systems to assure compliance with the requirements as interpreted by registrars, notified bodies, and regulatory agencies.

Beyond compliant processes, it’s necessary to focus on business process improvement. SAM offers consulting and training in Lean, Six Sigma, and operational excellence to give you the edge you need to be competitive in today’s ever-changing marketplace. For more information on these or other services, email customerservice@statamatrix.com, or call 800-472-6477.