Regulatory Affairs for Medical Devices

The healthcare industry is dynamic and full of exponential growth. In this innovative and regulated industry, it is essential for medical device professionals to understand the business, science and regulations in developing a medical device from concept to commercialization.

In this course students will develop an understanding of the regulatory affairs environment, how to navigate and work with the FDA; and the steps and timetable to develop and commercially market medical devices in the United States. It will also highlight post market compliance issues once a device has been commercialized.

This course is designed for individuals new to the medical device and biotechnology industries or who are considering a career in Quality, Regulatory Affairs or Project Management. Professionals employed in research and development, bioengineering, quality, regulatory, law, sales and marketing who are seeking a more comprehensive picture of the medical device regulatory process will also benefit.

Topics include:

• Working with the FDA
• Device Classifications
• Product development/approval process (IDE, 510(k), PMA)
• Post-market controls
• State and federal site inspections
• Enforcement activities
• Universal Device Identification
• International Marketing

Practical Skill Development:

• Understand the Product Development Life Cycle
• Preparations for State and Federal Inspections
• How to work proactively with the FDA and California State FDB
• Understand International Regulations

The cornerstone in the efficient manufacturing of a medical device is the implementation of a quality management system. Medical Device companies are required to develop a QMS that conforms to the regulations imposed by the FDA and ISO 13485 to ensure the safety of a medical device on the market.

This course will provide an in depth look into the FDA Quality System Regulation (21CFR820), and International Standard ISO 13485 for Quality Management Systems. You will also learn the related aspects of Risk Management and Medical Device Reporting.

Topics include:

• Design, Document , Production and Process Control
• CAPA
• Risk Management
• Medical Device Reporting

Practical Skills:

• Understand what a Quality Management System is
• Understand how a Quality Management System works practically in a Medical Device company
• Understand the elements of a Quality Management System and how they work together
• Know how to design an FDA/ISO compliant Quality Management System
• Know how to development a complete set of Quality Management System procedures
• Know how to implement an appropriate Quality Management System for a Medical Device company

Developing a new medical device for commercialization is a complex process. The FDA has guidelines that provide a framework for designing and manufacturing medical devices.

This course will provide a detailed and practical overview of the design control process for medical device design and development. The course will cover design control under the FDA Quality System Regulation (21CFR820.30) and international Standard ISO 13485 for Quality Management Systems, in addition to the practical application in the design and development of electronic hardware, software, mechanical elements and labels. The course will also cover related aspects of associated Standards and Regulations such as Risk Management (ISO 14971), Usability (IEC 62366-1) and Software lifecycle (IEC 62304).

Topics Include:

• Initial Design Control Process
• Design Output Process
• Verification and Validation
• Design Transfer
• Tagging, Tracing, Packaging and labeling
• Risk Analysis

Practical Skill Development:

• Understand the overall Design Control process
• Understand the (10) elements of Design Control
• Know how to apply each element of Design Control to the most common design disciplines
• Know how to do Design Risk Analysis
• Know how to do tracing between Risk Analysis, Design Input, Design Output, Design Verification and Design Validation
• Know practical methods for Design Transfer and Design Review

Are you ready to enter your medical device into the commercial marketplace? This course covers the specifics of regulatory submissions made to the FDA for the purpose of placing a medical device on the commercial market. Submissions covered will include: pre-submissions (pre-IDE and pre-510(k)); IDE; PMA; and 510(k). Additionally international submissions for CE mark will also be introduced.

This workshop style course will offer students an opportunity to practice understanding and gathering the complex scientific information required in various regulatory submissions. You will examine the process of writing medical device submissions for regulatory agencies, both nationally and internationally and will culminate with a preparation of a sample 510(k) submission.

Topics include:

• Laws and regulations of medical devices
• Device classifications
• Product development process
• Submission structure and content.

Practical Skill Development:

• Understand medical device product classifications
• Understand the premarket submission process, including 510(k), PMA and IDE
• Introduce students to the international submissions required to obtain CE mark for medical devices.
• Competently use the FDA website to find information for preparation of a FDA regulatory submission.
• Understand all the sections of a 510(k) submission and how to gather the information required
• Prepare a sample 510(k) submission for a medical device.

Once a medical device is commercialized, FDA requirements mandate that a company must perform Post Market Surveillance (PMS) to ensure public safety and efficacy.

This course will provide a detailed training on a variety of Post Market Topics and will introduce professionals to the many typical situations they may be responsible for during the weeks, months and years after commercialization of a product. Learning will be done by studying regulations, investigating the history of other companies (particularly failures), and sharing experiences within the class.

Topics Include:

• Complaint Management
• Failure Investigations
• Recalls
• Internal Audits
• Inspection Management
• Marketing Material