Topic:  Consultants Series Part 3

Consulting 301 - FDA Medical Device Regulatory Process - How a consultant helps your company manage and adhere to FDA guidance

Consultant:  David Connor

Location: Zoom

Meeting starts at 7:00 PM.

Open to the public.  Networking from 6:30PM - 7 PM. 

Your registration confirmation email contains the zoom link - Please read the email confirmation completely.

Event Description:

The FDA medical device regulatory process will be discussed. You do not have to be familiar with the FDA regulatory process to get benefit from this meeting. This is an overview of the regulatory process and how a consultant will add value, whether you need to implement a regulatory process or have an existing process.  Come find out more about the process and where consultants have helped identify mistakes that often occur in this complicated process.

No Prior Knowledge Needed - You do not need to know anything about the regulatory process in order to understand this talk. You do not need to be a consultant. Anyone that wants to gain knowledge about this process should come.

Major Topics Include:

1. What is the FDA regulatory process

-An explanation of the Quality System Regulations (QSR)

2. Understanding Medical Device Risk:

-Class I, II, and II medical devices

-Application of the QSR depends on product risk

3. Major elements of the QSR

-A matrix showing the six major elements of the QSR

4. The 510(k) Premarket Notification:

-Used by the FDA to determine whether a medical device is substantially equivalent to a previously approved device.

5. Common Medical Device Processes Related to Engineering

-ISO 9001 design process

-FMEA, FMEDA, FMEPA: Failure mode analysis as part of the risk analysis process

-Design History File (DHF)

-Corrective Action and Preventive Action (CAPA)

-IEC 62304 Medical Device Software -Software life cycle processes

6. When to Implement a QSR

-Before starting the design process to mitigate risk, adhere to regulatory compliance standards, and ensure efficient development

7. QSR Implementation Strategies

-The system needs to be compliant with FDA rules

8. Areas for Opportunity for CNET Consultants

-Setup of purchased QSR documentation to meet specific operating process of the customer, particularly in the area of design process.

-Direct electrical, mechanical, optical consulting for elements of the device (with understanding of the product risk)

- Mistakes that often occur in the regulatory process

Note: None of the consultants in this series is a lawyer or accountant. Please consult with professionals in this fields. 

Speaker Biography:

David Connor is a seasoned IEEE product consultant with over three decades experience in product development for domestic and international markets. As president of Striper Solutions LLC, he specializes in product regulatory compliance, guiding businesses through the complexities of regulatory standards and providing solutions for critical EMC and safety product issues.