Integrated Clinical Evaluation Process Lindhe Xtend AB

Important results from the project

The objective of the project was to strengthen Lindhe Xtend´s knowledge in the field of Clinical Evaluations and create a structured process that is integrated into the product development work, from start to ready CE-market Medical Device Product.

Expected long term effects

The biggest effect of the project is the transfer of knowledge about how the entire process can be carried out from start to finish. The whole team can work in an efficient and safe way and has also worked on a practical project to create an Clinical Evaluation for one product. Lindhe Xtend´s process for Clinical Evaluation has improved and includes both early involvement of Clinical Evaluations in the product development process and a well-structured work with Post Market Clinical Follow-up.

Approach and implementation

The Project was run in three work packages: Work package 1 - Clinical Evaluation Process - Structure and process audit. Work package 2 - Practical implementation - Clinical Evaluation Xtend Foot gen 3. AP-3. Post Market Clinical Follow-up - implementation. The main focus was on knowledge transfer, several workshops, both physical and digital, took place within the framework of the project. In between, smaller groups have worked with certain parts of the project alongside individual work with sub-projects.