Design and Development review in ISO 13485

iso 13485 - review

The reviews in design and development stages are intended to help monitor during medical device product development to ensure the product design is effective, safe, and progressing. Medical device companies are obligated by the ISO 13485 standard to perform systematic reviews of design and development at suitable stages, by planned and documented arrangements to:

  • evaluate the ability of the results of design and development to meet requirements.
  • identify and propose necessary actions.

To achieve that the outputs are accepted as planned and comply with the requirements; the standard requires you to create a process where all the design and development processes are controlled. The aspects of the review will be determined, such as:

  • When the review takes place
  • What are the issues to be reviewed
  • The type of review
  • Which records and development outputs are required to be reviewed
  • Preceding activities for the review
  • The process of the review; for each reviewed milestone, the method shall indicate the exact way in which it will be reviewed
  • The expected records of the review

Definition of reviews

The definition of reviews will be documented in the procedure mentioned in subclause Design and Development Planning. The milestones will be defined in the plan. For the milestones, the Meddev company is required to define the control and review.

Every medical device company must define the data and information to be presented in the review. For the success of medical device product development, reviews in design and development stages are crucial. The parties that are part of or affect the design and development milestone or process should be included in the review. The experts should attend the review as it’s the standards require that should refer to subclauses Responsibility and Authority and Human Resources. Everything has to be documented by the standard, therefore this isn’t an exception, it can be documented in many ways such as development plans, work instructions, job descriptions, or procedures.

The matters or issues related to the design and development that are going to be reviewed will be discussed in the following. The main objective of the review is to determine and evaluate if the design and development are progressing according to set requirements and goals. The medical device has to be examined to check if it’s going to answer the expectation. The criteria for evaluation have to be set, and it is documented foundation for evaluation and reference on whether design and development outputs have achieved their goals. The evaluation will assess all of the design and development parts, because of this, for every aspect, it is required of a medical device company to define the criteria for the accomplishment of the review. The level of complexity and formality of the review will be determined according to the nature of the medical device.

As mentioned, the review is intended to have outputs –reports, tasks, summaries, and procedure updates. The outputs of the design and development review are defined in the plan, documented, and maintained. The format or media that a company will use isn’t specified by the ISO standard. It is on the organization to decide what will be used. These records are part of the quality records and will be submitted to the control of quality records in the quality management system as required in subclause Control of Records.

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One reply to “Design and Development review in ISO 13485”

  1. Angela O'Reilly says:

    Is there an exemption for Class 1 medical devices and if so does this apply only where the regional regulatory requirements allow this?

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