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Design and Development Plan

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In this article, we want to give you a deep dive into the requirements associated to the Design and Development Plan. As you know, the Design Process for medical devices can be quite complete, with a lot of interconnection between the different departments of the organisation. As we already discussed, the design process is documented through the so-called Design History File, a collection of documentation and records related to the different phase of the Design Process. If we use the classic V-cycle to represent the different phase of the design process, the design plan represents the first step. It is important to mention that we are talking about the planning for the overall Design Process, and not about the Software Development Plan, which is a specific requirements related to the IEC 62304.

In this article, we will give a broad overview of the requirements of the Design and Development Plan, mainly focusing on three different regulations:

Design and Development Plan Requirements According to ISO 13485:2016

The requirements associated to the Design and Development Plan according to the ISO 13485:2016 are reported in the section 7.3.2. Basically, the Design Plan is considered a tool for the control of the design process and it shall be updated through the whole process. There are specific requirements for what shall be included in the plan, as per scheme below:

Design and Development Plan

Stages of Design and Development

In this section, we need to include the different milestones of the design process, from conception and prototype until the release of the devices on the market upon successful completion of the . In this part of the plan, it is also important to highlight the interactions which the different departments of the organization shall have in order to proceed through the design process: R&D, Quality, Marketing, Purchase & Supplier Management, are all departments which could definitely contribute to the design process.

Design Review Needed at each stage of the process

As we know, at the proceed of the design process, it is essential to perform Design Review where the results of the design process are going to be reviewed and decisions are taken in order to move forward according to the Design Plan. It is essential to provide in the Design Plan the stages of the design process where the review will be conducted.

Verification, Validation and Design Transfer.

As discussed in some previous posts in the QualityMedDev website, verification, validation and design transfer are key phases of the Design Process. It is necessary to define, in the Design and Development Plan, the activities related to verification and validation necessary in the specific stage of the process. If the device is constituted by hardware and software, this shall be reflected into the design plan and the activities for software verification and validation shall be included.

Responsibilities and Authorities

It is very important that responsibilities for the different phases and activities of the design process are documented in the Design and Development Plan. It is essential to have documentation fully aligned between the responsibilities mentioned din the Design and Development Plan and the related Job Description and trainings associated to the personnel involved in the Design Process.

Traceability through the Design Process

Key requirements is the traceability through design process between design inputs and design outputs. This is sometimes documented through the so-called Design Traceability Matrix, which provides the link between:

  • Design Inputs
  • Design Outputs
  • Risk Associated to the specific design requirements
  • Verification activities used to verify the specific requirements and/or to mitigate the specific risks.

The Traceability Matrix will cover the requirements to have traceability through the Design Process but as well the traceability-related requirements mentioned in the ISO 14971, where in fact the link between risks, risk control measures and verification of the risk control measures shall be maintained and documented.

Resources Needed

The need of resources for the design process shall be mentioned in the Design and Development Plan. This section requirements shall be covered as well in the section related to “Responsibilities and Authorities”.

Design and Development Plan according to FDA regulation

As we know, FDA Quality System Regulations specifies the requirements related to Design and Development in the section 21 CFR 820.30. Specifically, 21 CFR 820.30 (b) contains the requirements for the design and development plan. The text of this part of the regulation is reported below:

Each manufacturer shall establish and maintain plans that describe or reference the design and development activities and define responsibility for implementation. The plans shall identify and describe the interfaces with different groups or activities that provide, or result in, input to the design and development process. The plans shall be reviewed, updated, and approved as design and development evolves.

As you can see, there is no much differences with the requirements mentioned in the ISO 13485:2016 and the two regulations are very similar. Basically, we can say that by preparing a Design and Development Plan compliant with ISO 13485:2016, we will automatically cover the requirements associated to 21 CFR 820.30 (b).

MDSAP Requirements for Design and Development Plan

In the framework of MDSAP regulation, there are basically no additional requirements associated to the Design and Development Plan compared to the ones already described for the ISO 13485.

Australia and Canada specifies that the Design and Development Plan could be documented as part of the Quality Plan. This is in fact a specific requirements for Health Canada for Class IV devices.

Conclusions

In conclusions, the design and development plan is an essential document for the design process of medical devices. We have been covering, in this article, the main requirements associated to the design plan, according to different medical device regulations and ISO standard.

Do not forget that the design and development plan is a document that shall be continuously updated through the whole design process and auditors are expecting to see evidences that the plan has been modified and updated to reflect the actual proceed of the design process.

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Source: https://www.qualitymeddev.com/2021/03/29/design-and-development-plan/

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