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Medical Devices
The Regulations that govern medical devices vary from region to region and are comprised by a similar set of basic requirements. The differences in the various regions present a peculiar challenge because manufacturers of medical devices usually set their goals on marketing the device in multiple regions. The challenges and requirements for medical devices therefore present a daunting task to ensure compliance with all requirements.
A list of requirements during the design input phase of product development will ensure that any regional requirements are incorporated into the device's development phase. A typical requirements plan will look at specific requirements:
Table of Contents
Responsibilities
Product/solution identification
Project Description:
Device/solution description
Device/solution variants
Components and accessories
Device/solution features/claims
Inter device description
Intended use
Indications for use
Contra-indications
Target market
Patient/user contact
History of similar devices
Quality history or detailed explanation of complaint
Regulatory classification and tasks
Applicable product classification
Classification according to Australian medical device
regulatory system
Classifications according to Canadian Medical Device Regulation
Classification according to Chinese SFDA order number
Classification according to MDD 93/42/EEC directive
Classification according to United States Food & Drug Association (FDA)
Classifications according to GHTF
Classifications according to other regulations if known
Supplier audit requirements
Regulatory registration activities
Clinical evidence requirements
The above lists a partial list of requirements for the Design Input phase of the development of medical devices. As you note "Regulatory Requirements" are an important element in the overall scheme. From here you can determine if there are particular requirements for the device. For instance ISO 14971 may be a requirement in some countries....it may be a recognized standard in another. Should a company proceed to develope their medical devices without consulting the necessary requirements they would be surprised to find out that the local agencies require specific information (i.e. a 14971 type Risk Management Plan).
Therefore, ensure that your regulatory team specifically addresses all regulatory requirements early in the development of the medical device.
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