The method
At CompliancePal we believe that regulatory activities brings real benefits to medical software products. Quality of regulated software is driven by both the talent of its creators and how they feel while they are crafting it.
Regulatory documentation should be the byproduct of robust software development process, as a natural outcome of the work that is already being done by the team. It should not be a separate activity that is done as an afterthought.
When possible, the outcomes should be used to satisfy the needs of other stakeholders. For example, the same documentation can be used to satisfy the needs of the auditors, the customers, the sales team, the marketing team, the support team, and the developers themselves.
To bring back the right focus, these are the foundational and evolving ideas CompliancePal is built on.