Maren Wiese

4 month interim management representative for a customer selling orthopaedic devices (Class I - III) and single point of contact for the notified body Project lead for MDR implementation projects for medical devices and combination products (MDR Article 117 and EMA draft guideline) Project lead for various other projects (Regulatory Reporting, Outsourcing Strategy, QMS Remediation) Training and workshop creation and conduction Development of consulting offers and compilation of marketing content

Global and local Quality management system development, maintenance, and improvement (Hamburg/Germany, Suzhou/China, Bangalore and Pune/India) Internal Audit Program Manager (managing site and outsourced processes) Lead Auditor/Auditor, gained audit experience European wide Hosting of multiple Notified Body Audits (incl. MDSAP) and Regulatory Authority Inspections (US FDA, Anvisa Brazil, German Authority) International support of FDA inspections (Katowice/Poland, Solna/Sweden, Haifa/Israel)

- Improvement and maintenance of the quality management system within the production - Implementation of APQP - internal and external audits

Meine Aufgaben sind: - Beschwerden bearbeiten, Meldeentscheidungen treffen und meldepflichtige Vorfälle an die Behörden melden (international) - Betreuung eines OEM Lieferanten im Bereich Post Market - Interne Audits und externe Audits

In terms of my diploma thesis I developed a risk based validation procedure for production and quality software of medical class III devices. As part of that I revised and developed standard operation procedures, wrote test and validation protocols and performed the whole validation.

My main issue was to ensure the usability of two devices and the associated computer games. The devices are developed to help stroke patients to improve their upper limb movements. Via case studies I have identified potential improvements and modified the user interface. Furthermore I developed user manuals for the final release.

I was part in the project ’Microfluidics in Medical technology’ and my work consisted of: - Carrying out of flow measurements on microvalves for drug dosage at nanoliter per minute scale - Optimization of flow, temperature and pressure measurement setups - Chemical and manual microscope-supported cleaning of microvalves for ultra pure water applications - Manufacturing and casting of implantable silicon-elastomer parts - Carrying out and evaluating evaporating measurements with capillaries for drug dosage

Working in a cafe for homeless people and living together with some formerly homeless people due to resocialisation.

Development of medical devices