(CMDCA) Certified Medical Device Compliance Auditor

In March of 2016, the International Organization for Standardization made significant changes to ISO 13485—last updated in 2003. This standard directly influences laws and regulations in both the United States and Europe with "credible guidance governing documentation for quality systems." In plain language, ISO 13485 requires a comprehensive Quality Management System (QMS) applied to the design and manufacture of medical devices. The industry has three years in which to adopt the revised standard—beginning with the date of adoption.

What Will Change?

Every medical device manufacturer will need to perform internal audits, which begin with a Gap Assessment that measures existing systems against the standard. The required changes will also mandate supplier audits—with the Lead Auditor assuming responsibility. Successful planning and a thorough Gap Assessment will allow the manufacturer to put plans in place so that they—and their suppliers—can meet the standard within the provided timeline. The changes which will go into effect under the March 2016 revision of ISO 13485 will include:

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  • Alignment of global regulatory requirements
  • Risk management/risk-based decision making throughout QMS
  • New requirements regarding validation, verification, and design
  • Strengthening of supplier control processes
  • Increased focus regarding feedback mechanisms

How Can You Prepare?

With these looming changes in mind, CfPIE is proud to offer a Certified Medical Device Compliance Auditor™ (CMDCA) program designed for all types of auditors—including supplier, internal, and lead. This certified medical auditor program will help personnel who work with medical devices and combination products. This new program allows manufacturers to teach their quality associates—whether they are new or current auditors—how to effectively audit in compliance with both FDA and EU regulations.

Why Certify?

As the deadline for compliance draws near, the rush to gain certification will place a heavy burden on the notifying bodies within the European Union and potentially create a backlog. Early action enables medical device manufacturers to get ahead of the certification process and avoid costly delays.

Who Should Enroll?

The Certified Medical Device Compliance Auditor (CMDCA) program will provide attendees with the general skills to audit based on ISO 19011 and the technical understanding of the changes to ISO 13485:2016. This content is of particular importance to companies and individuals who will be involved in the transition from ISO 13485:2003 to the new version of the standard. Topics covered in this medical device course will include general auditing skills with a focus on Gap Assessments to conform to ISO 13585:2016. Additionally, this program provides the flexibility to tailor your certification to meet your specific educational objectives.

 

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Certification Requirements:

  1. The completion of the following 3 courses will be required for certification.  Each course includes and exam which must be completed within 10 days after the end of the course.  A score of 70% or better must be achieved on each exam in order to become Certified.

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Skill Level

Course Name

Advanced

Medical Device Auditing: EN ISO 13485:2016 Changes

Advanced

Medical Device Auditing Course: ISO 19011:2011 Framework

Advanced

Overview of FDA Regulatory Compliance for Medical Devices

 

For more information, call us at 1-610-648-7550 or contact us.

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