Compliance Management Plan and the Regulatory Environment is Part 3 of the blog series Designing for Compliance, outlining the benefits, procedures, risks, etc. of designing a product with compliance regulations in the design forefront, rather than the typical afterthought.
Compliance Management Plan
When designing with a compliance program in mind, success requires performance from an effective compliance management plan. Let’s again refer to Table 1, which details the benefits of designing for compliance:
Table 1. Compliance management program benefits.
Basic rules and guidelines must be followed to achieve such benefits. In the compliance management plan, consideration of several fundamental components is essential:
We’ll dive into detail about the Regulatory Environment today, and the remaining components in future blogs.
Research of the regulatory environment for new products takes time, but the rewards can be significant. Researchers first need to ask where and to whom the product will be marketed. The answers to these questions will help determine whether existing standards meet the needs of the product being developed.
When deciding, a few key elements must be considered:
Definition of the regulatory environment for each target market.
Highlight of essential requirements for the technology and identification of the applicable standards.
Impact assessment of any nonessential criteria that can apply, depending on the technology.
Determination of whether the essential requirements address the selected technology for each target market. If it is determined that the essential requirement standards do not meet the technological needs, then it is necessary to generate and implement a strategy for standards lobbying. If this is required, beware of hidden costs in the lobbying process:
A thorough understanding of your regulatory environment is the first, and perhaps most crucial, step toward designing a product with compliance standards in mind.