The ASQ CMDA program aims to cultivate professionals for the medical device industry by systematically assessing their knowledge and skills in medical device technology.

1. Introduction to the Certified Medical Device Auditor certification

ASQ Certified Medical Device Auditor (CMDA) is a specialized certification for the medical device industry issued by the American Society for Quality, focusing on verifying the professional abilities of practitioners in the field of medical device quality system audits.

CMDA is the "gold standard" in the field of medical device quality compliance, aimed at cultivating professional auditors who can systematically evaluate the compliance of medical device quality management systems, identify risks, and promote continuous quality improvement. It is the core professional credential for quality, compliance, and audit positions in the medical device industry.

Medical devices are directly related to public health and safety, and their quality system must strictly comply with global regulatory requirements. The core of CMDA certification is to cultivate "medical device quality system professional audit experts." Not just simple inspectors, but composite talents who can deeply understand medical device regulations, standards, and quality system requirements, use professional audit techniques to evaluate the effectiveness of the system, identify compliance risks, and provide improvement suggestions.

When auditing medical device manufacturers, CMDA licensees will systematically evaluate whether their quality systems comply with standards such as ISO 13485, FDA 21 CFR Part 820; identify potential compliance risks and propose targeted improvement plans; provide professional support for enterprises to respond to regulatory inspections and ensure the quality and safety of medical devices throughout their entire lifecycle.

2. The Competitive Edge of CMDA Certification

CMDA is a globally recognized top-level audit certification in the field of medical devices, and ASQ brand has a high degree of recognition among multinational medical device companies and regulatory agencies.

When recruiting for core positions in medical equipment auditing and compliance, they are often listed as "priority or necessary conditions," especially when third-party auditing agencies and large medical device companies recruit auditors, CMDA is the core admission qualification. Internationally, the average annual salary of certified individuals is 25%-40% higher than that of uncertified individuals.

CMDA certification covers the core requirements for the full lifecycle audit of medical equipment, integrating specialized regulations, risk management, design control, and other special points. After passing, it can prove the ability to independently perform professional medical equipment audits, accurately identify quality risks and compliance loopholes, reduce regulatory penalties for enterprises, and undertake core audit projects without relying on external experts.

Holders of CMDA certification can join the ASQ global membership community to access the latest updates on medical device regulations, review best practices, and industry benchmark cases; prioritize participation in ASQ International Medical Equipment Quality Conference and specialized seminars, connect with global medical equipment audit expert resources, expand professional horizons and high-end cooperation opportunities.

3. Core Components of the CMDA Certification

For quality practitioners who are committed to establishing professional audit capabilities in the highly regulated field of medical devices, medical device audit professional certification is a highly authoritative professional qualification.

This certification systematically covers the complete knowledge system required for the full lifecycle audit of medical devices, aiming to comprehensively verify whether you have the professional ability to independently perform medical device audits that comply with global mainstream regulatory requirements.

The foundation and process of auditing are the methodological basis for conducting auditing work. You need to have a deep understanding of the basic principles, types, and complete processes of medical device audits, from audit planning and on-site execution to discovery reporting and follow-up tracking, and establish a systematic audit thinking framework.

The medical device regulatory system requires you to be proficient in the specific requirements of global core regulations such as ISO 13485, FDA 21 CFR Part 820, and EU MDR. This is the fundamental basis for evaluating whether an organization's quality management system meets regulatory requirements.

Technical knowledge and risk management are the professional core of certification. You need to master the audit points of key technical processes such as medical device design and development, production control, sterilization verification, etc., and be proficient in applying ISO 14971 risk management standards to evaluate the safety and effectiveness of products.

Given the unique nature of medical devices, you will learn about the audit requirements in professional fields such as biocompatibility evaluation, software lifecycle management, and sterility assurance, and possess the ability to assess complex technical issues.

The application of auditing techniques requires you to master advanced auditing techniques such as statistical sampling and root cause analysis, be able to identify systematic problems, and propose practical and feasible improvement suggestions.

In summary, obtaining CMDA certification not only demonstrates your expert level ability to conduct medical device audits in accordance with international standards, but also showcases your professional value as an effective "gatekeeper" for medical device safety. It is an important milestone in establishing your personal professional brand in the field of medical device quality.

4. What are the requirements to be an ASQ Certified Medical Device Auditor?

(1) Qualification prerequisites:

The prerequisite for obtaining ASQ Certified Medical Device Auditor (CMDA) certification is education and experience.

For certifiers with a bachelor's degree or above, they need to have 3 years of full-time work experience in medical device related fields. For certifiers with a college degree, they need to have 5 years of full-time work experience in medical device related fields. For certifiers with a high school degree, they need to have 8 years of full-time work experience in medical device related fields.

In addition, the applicant needs to have at least 2 complete medical device quality system audits, which can be completed before or after the application. 

(2) Training and examinations:

The ASQ Certified Medical Device Auditor (CMDA) certification includes 145 multiple-choice questions and case analysis questions. The exam duration includes 12 minutes of preparation time, totaling 270 minutes. The exam has a maximum score of 750, and passing with a score of 550 or above is required. The exam fee is $433 for ASQ members and $533 for non-members. 

(3) Qualification maintenance:

The ASQ Certified Medical Device Auditor (CMDA) certificate is valid for 3 years, and the renewal requirement is to accumulate 30 Continuing Education Units (CEUs) within 3 years. The renewal fee is approximately $150.

5. Comparable Certifications to ASQ Certified Medical Device Auditor Certification

• Certified Biomedical Auditor (CBA)
• IRCA ISO 13485 Lead Auditor
• CCAA ISO 13485 Auditor
• Exemplar Global ISO 13485 Lead Auditor