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.