In the medical device development, the Design Control process is an essential part to ensure compliance with norms such as ISO 13485, 21 CFR Part 820, ISO 14971 or IEC/ISO 62304. There are few steps in the Design Control process, but they need to be conducted very carefully to ensure quality and regulatory compliance:

  1. Collect requirements from relevant stakeholders
  2. Create Design Input
  3. Medical Device Design
  4. Create Design Output and perform verification against approved Design Inputs
  5. Produce Medical Device and perform validation against approved requirements

Collect Requirements

By gathering the requirements from all relevant stakeholders, a project team ensures that they did not forget any key element to the future Medical Device. These requirements can be based on norms, existing customer feedback, technological advances, legal frameworks or financial aspects. To respect ISO 13485 and FDA 21 CFR Part 820, any constraint that can limit or direct the development of a Medical Device should be listed as a requirement to fulfil.

Design Input

By freezing the Design Input, the gathered requirements for the Medical Device are assessed and the feasibility is proven. Furthermore the intended use of the Medical Product is established and development of the solution can begin.

Medical Device Design and Design Output

During the design of the Medical Device, requirements are fulfilled step by step. This process finally ends in a Medical Device which from a technological point of view is ready for the market. According to ISO 13485 and FDA 21 CFR Part 820 the finalisation of the Medical Device also includes the labelling and documentation besides the final product itself. Oftentimes the focus is on the Medical Device itself and the labelling has a bit less focus – this can be a source of challenges in finalising the product and making it ready for the market.


Verification of Design Inputs

In alignment with ISO 13485 and FDA 21 CFR Part 820, the verification of Design inputs is a critical element in the development of a Medical Device. With the verification procedures, it is ensured that a Medical Device is created according to the requirements and specifications which were frozen at the end of the Design Input. The verification phase also helps identifying potential improvements in the area of user experience and handling of the Medical Device itself. During the verification of the final Medical Device, the final product can be used for the first time in its Life Cycle.


Validation of the intended use

After a successful verification, the validation is performed with regards to the intended use of the Medical Device. With the validation of the Medical Device by qualified personnel, the intended use is assessed best. A thorough validation of the finalised Medical Device is the final step to ensure market readiness. The positive result of the final Medical Device validation triggers the start of commercialisation activities in the targeted markets and a new phase in the Life Cycle of the Medical Device. Since this step is essential in the whole Life Cycle of the Medical Device, it also has an important standing within the ISO 13485 and FDA 21 CFR Part 820 respectively. 

To master potential challenges with regards to Design Control, the elicitation of requirements or also in the area of Verification & Validation, rameus solution offers additional services such as Norms & Regulations, Risk Management or general topics such as Strategy Solutions, Quality AssuranceAudits/Inspections and Process Management.


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