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Regulatory Strategy

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regulatory strategy is a formal document that aligns the regulatory activities to bring a new or modified product to market with the business strategy for that product. It provides overall definition and direction to the project team for the product being developed by identifying the important regulatory elements to be addressed to market the device.

A strategy starts with the collaboration of a cross functional team to identify important questions about the product. Other considerations are the type of Regulatory submission, device risks, and any lifecycle considerations. Regulatory Strategies should be living documents that are reviewed and updated as the project evolves.

  • A business strategy is one of the foundations upon which successful product development is based. Conducting regulatory intelligence to obtain as much information as possible about the regulation of similar or related products.
  • Validate your strategy with internal and external stakeholders, with agency personnel.
  • Internally driven changes, that may sometimes difficult for the employees to adjust.
  • Difficult to capture new markets.

Why is Data Governance Framework important now?

  1. Gathering key or significant information –
    The first key point focuses on the acquisition of information i.e. researching governing bodies’ rules and regulations, to researching what industry thought leaders have published on a particular topic. Knowledge is power, and the more information obtained can lead to sound decision making.
  2. Processing/analyzing information to understand its relevance-
    Another area to consider is the analysis of the information collected and consideration should be taken in the fact that regulations and standards may vary from country to country.
  3. Finally, developing a regulatory strategy –
    A regulatory strategy should be a living document that allows the flexibility for the first two points to continue to flow and for adjustments to be made.