Thiết kế & Kiểm soát Phát triển Thiết bị Y tế. ISO 13485.

The course is broken into 10 sections. The objective of the course is to explain what is the standard requirement for medical device design and development control. What does the medical device designer needs to do in order to be be compliant to design and therefore get approval from a regulatory authority to be able to sell the device on the market place.

It follows sections 7.3 of the ISO 13485 standard for design and development control of a medical device. It also references MDR 2017/745 and CFR 820.30. It will explain what needs to be done gain approval in the US, EU and globally.

In the introduction I will explain the famous Waterfall design diagram and I validate this explanation in the recap lecture.

I have attached resources such as quizzes, standards, regulations, guide lines, templates and case studies.

In Section 1: General/Design & Development planning.

In this section we will examine section 7.3.1 & 7.3.2 of the standard which explains that design and development needs to be planned and this planning process must be documented.

To give context to the design and development process and to help to understand it better we will look at an example of a medical device which is a stent. We will use this example throughout the design process to illustrate better understanding.

Section 2: User need/Intended Purpose.

In Section two we will understand what is meant by “Intended Purpose” what do we want the medical device to do. What disease is it going to treat.

Once we have defined the intended purpose, we need to understand what the user needs are and where do they come from. This can come from a lot of sources, and we will explain that. One main point here is stakeholders have different opinions on what they need the device to do.

Section 3 Design & Development Inputs.

We need to understand how the User needs which is what the user wants. We need to learn how to translate this into a how.

With this we will look at how important traceability is. Each step in the process is linked and I will explain this via the Input Output Verification Validation matrix. IOVV.

We will understand how risk analysis must be used to identify any risks which will lead to amendments in the design.

Section 4: Design & Development Outputs.

In this section design outputs are explained. In my simple definition the design outputs are the specification of the product.

I will explain the design outputs must satisfy the design inputs.

Section 5: Design & Development Review.

We will understand that at each stage of the design and development process there should be a review of the design process. It needs to be documented and a person in authority within the organization must sign off on the review to allow it to go to the next stage.

Section 6: Design & Development Verification

We will understand what the ISO 13485 standards says about Design and Development Verification. Which is in section 7.3.6 of the standard.

We will understand what verification is. You are ensuring that the specification of the device is correct.

I will explain what verification tests are by way of illustration with examples.

Section 7 Design and Development Validation

I will explain what the standard says about validation.

I will explain what it is in simple terms. Is the device functioning as we intend it.

Section 8 Design and Development Transfer:

What is meant by design transfer. The product must eventually be made and sold in the marketplace. I will explain how this is going to be done.

I will explain in a case study how important design transfer is.

Section 9 Design and Development changes

Design Changes need to be controlled. I will explain how this needs to be done.

I will discuss how important it is to control these changes via a case study.

Section 10 Design and development Technical files.

We need to understand that the whole design control process needs to be documented, recorded and stored.

We will look at Design History File, Device Master Record, Device History Record which is associated with the US regulation and the Technical documentation which is associated with the European Union Regulation.