Understand approval procedures before they cost you time

Anyone who takes a product through an approval or certification process often only realizes where the problems lie during the testing process. Requirements have been interpreted differently than the inspector expected. Evidence is missing or does not correspond to what the testing body actually needs. The scope was defined too broadly or too narrowly. Roles and responsibilities were clarified too late. Safety inspections were incorrectly assessed. There are many points at which an approval process comes to a standstill, and most of these could have been avoided with structured preparation.

SRC offers manufacturers and operators the opportunity to set up this process more solidly from the outset. Not as advice, but as structured preparation by a body that works with test procedures on a daily basis and knows how requirements are assessed in practice.

Knowing early on what really counts

The starting point is always the question of which approval is being sought and what this specifically requires. Based on this, it is possible to clarify which verifications are necessary, how the scope of the test or test object can be meaningfully defined and which safety tests are actually relevant for which requirements. Making this classification at an early stage prevents gaps arising at the end of the project that delay the entire process.

A realistic time and milestone plan is not an administrative act, but a genuine management tool. It makes it clear when which evidence must be ready, where the dependencies between development and documentation lie and how resources and roles are sensibly distributed.

Fewer loops, shorter running times

In practice, it has been shown that structured support significantly reduces typical frictional losses in the approval process. Misunderstandings about requirements are clarified at an early stage, not just before the assessment. Evidence is created in parallel with development. The review process begins with a reliable basis instead of open questions. In individual projects, this has led to a reduction in the overall runtime of up to fifty percent, especially as, depending on the testing scheme, parts of the testing can be started during development if the planning is good.

SRC does not take on an advisory role for implementation in the regulatory sense; the audit competence remains clearly separated. What emerges is a shared understanding of what a procedure really requires before it becomes expensive not to know.

What is typically part of the approval process

• Classification of the intended approval and the associated requirements vis-à-vis BSI, gematik or other bodies
• Creation of a time and milestone plan with kick-off, provision of evidence and review period
• Definition of the test scope
• Planning of safety inspections including cost estimates
• Information on the necessary verification documents and, if necessary, testing as well as the involvement of independent experts who can support the client in providing verification if required
• Optimization of resources and role planning for the testing and approval process
• Regular coordination meetings during the project to address questions and problems as early as possible
• Workshops on specific topics (optional)