A Comprehensive Approach to Standards and Regulatory Compliance

The Strategic Compliance Process: A strategic approach to compliance assures that all applicable requirements (currently and in the foreseeable future) are identified for markets where the equipment will be sold. This must be done as early in the design process as possible. The requirements must then be translated into specific and practical design requirements and executed efficiently. In essence, when the requirements for achieving certification (by UL, CSA or other certification bodies) and receiving regulatory approval are integrated into the product development process, there are few costly surprises and the shortest path to market is assured.

To achieve this level of performance, it is necessary to understand what customers, certification bodies and regulators expect and to be able to articulate those expectations in terms of your product development processes and the concept being developed. It is also necessary to have specific knowledge of changes in those requirements that may take place during the development of the product and throughout its production in advance.

Knowledge of the regulatory and compliance environment translates directly into competitive advantage and the bottom line. However, the required level of expertise can be expensive to maintain. Strategic Device Compliance Services offers over 20 years of experience in the design and manufacturing of medical devices.

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