Designing Products for Quality, Regulatory and Lean Production

Smart methods and early overview to manage requirements with minimum effort into successful products.

Employees can use their full creativity

only if there is sufficient “space” for this. This is even more true where products and processes must be compliant with regulatory requirements.

We support our clients with two approaches:

Systematic management along requirements from very early stages, tipically
– Customer requirements
– Sourcing requirements
– Quality requirements also covering process controls
– Regulatory requirements considering international complexity

In doing so, inefficient loops are avoided, validation is a walk in the park, operations processes are capable, cost targets are met and as a result, quality performance is high. Here, we apply and pass on our deep expertise in statistics and Lean, 15+ years of improving regulated processes, and background of DIN ISO 8…

Design the design process so it frees up maximum creative potential while meeting regulatory requirements and becoming lean.
We build on:
– Understanding regulatory requirements
– Eliminating process waste
– Efficient cooperation through transparency
– Easy-to-implement statistics
– Methods and standards driving efficiency and quality (e.g. Agile, Robust Design, Design of Experiments)

New Product Introduction

We supported a global Medical Diagnostics Company to improve their new product introduction process by piloting and customizing state-of-the-art methodologies followed by a global training and roll-out process, reducing pre-launch efforts by 50%.

Transferring Design into Capable Production Processes

A medical devices company found that often many loops where required to manufacture new or modified products. We supported the set-up of a practical cross-departmental process based on methods and its implementation including review routines and dashboards in daily operations.