Design controls for medical devices

 

Design controls for medical devices demonstrate that the medical devices are safe, effective, and meet the indications for use. A medical device design that adds value to end user and simultaneously captures profitable market share is really a tough job. Design controls for medical devices and development of a medical device is the most crucial phase for its success. A loosely-defined and designed medical device cannot comply with the regulatory needs and make it to market. 

Medical devices, like all products and software, are constantly evolving. Yet, due to the nature of medical devices and their impact on personal health and safety, the entire product life cycle of a Design controls for medical devices must be carefully documented. 

Design controls for medical devices

Design controls are a set of management practices used to controls the process of design and development of medical devices. They should ensure that your process delivers a blueprint for a safe product, which will function according to documented specifications.

These controls should provide for an iterative design process with regular checks against specifications and relevant regulations, meaning that you can reduce the risks of omission and the amplification of mistakes as you go along. In fact this iterative phased approach is not only the best commercial practice, it is a legal requirement. The FDA, the MHRA, ISO 13485 and all require that Design controls for medical devices is undertaken like this meaning that you cannot legally launch a device in any major market without proving that you have been working in this way.

FDA Design Controls for Medical Devices

The Design control for medical devices follows a set of practices and procedures that help medical product developers:

1. Manage quality.
2. Ensure each product meets all requirements.
3. Prevent potential issues or recalls in the future.

Medical design control stages from both the FDA and the ISO consist of:

• Design & development planning.
• Design inputs.
• Design outputs.
• Design review.
• Design verification.
• Design validation.
• Design transfer.
• Design changes.
• Design history file.

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