Service Highlight

MDR Implementation at KH Medical

The MDR in combination with ISO 13485:2016 implies an "end-to-end" surveillance along the entire value chain. KH Medical illustrates a way how to implement these new requirements in four steps.

Kunststoff Helmbrechts AG is a globally established company, specializing in the manufacturing of plastic injection molding parts. KH Medical is a 100% subsidiary focused on 1-3k components for single-use devices and as well as their assembly in a clean room.

As contract manufacturer for reputable customers, KH Medical gets prepared for the new requirements in conjuction with the implementation of MDR. They are derives from two sides:

- ISO 13485:2016 chapter 1 "Scope": External processes must be treated equally to internal processes

- MDR Article 10 (15): All subcontractors must be identified

- MDR Annex I (10.4.2): Justification of using CMR substances

- MDR Annex VIII chapter 3 (7.6): Reclassification if nanomaterials are used

In fact, this implicates an "end-to-end" surveillance of the entire value chain - from the raw material to the final product.

To fulfill this requirement, KH-Medical uses the following approach:

- Step 1: Definition of process-codes with ID

- Step 2: Verification of process-controls (each ID)

- Step 3: Listing and approval/release of all contact materials

- Step 4: Documentation / report generation

The documentation is provided to the legal manufacturer for the technical file.