1. Quality System for Biomedical Equipment Development in the Industry-Academic Cooperation Dipl.-Ing. Juergen Schmitt, Experto alemán SES, ex Heilige GmbH, Friburgo, Alemania Jürgen Schmitt, SES1

2. Content Personal Introduction Quality Management: – key concepts – key elements – is QM required? QM for Biomedical Engineering Academic / Industrial Cooperation Summary Jürgen Schmitt, SES2

3. Personal Introduction 2016SES project with NIB, Montevideo 2014 Retirement, SES Expert 2005 – 2014Quality Auditor, GE HealthCare 1996 – 2005Quality Manager, GE HealthCare 1992 – 1996Design Manager Application Software, Marquette-Hellige 1976 – 1991Design Engineer, Hellige 1972 – 1975Design Engineer, Nixdorf Computer AG 1972Graduation as Dipl. Ing. (FH) for Electronics and Control Engineering Jürgen Schmitt, SES3

4. This is a story about four people named Everybody, Somebody, Anybody and Nobody: There was an important job to be done and Everybody was sure that Somebody would do it. Anybody could have done it, but Nobody did it. Somebody got angry about that, because it was Everybody’s job. Everybody thought Anybody could do it, but Nobody realized that Everybody wouldn’t do it. It ended up that Everybody blamed Somebody when Nobody did what Anybody could have done. Jürgen Schmitt, SES4 Quality Management, key concepts

5. Planning – “think first than act” – Goals – Time – Resources – plans are to be updated Jürgen Schmitt, SES5

6. Quality Management, key concepts Process approach “do it right the first time” (better “try to do it right…”) trial & error is OK as long as we learn from errors no surprises, always having everything under control (examples: Emergency Plans, Deviations) Jürgen Schmitt, SES6 Process InputOutput

7. Quality Management, key elements Organisation Resources (Human, Equipment, Premises) Improvement: Corrective and Preventive Action Documentation Jürgen Schmitt, SES7

8. Quality Management, key elements Marketing & Sales Design/Development control Production control (production = materialization of design) Material control Jürgen Schmitt, SES8

9. Quality Management Systems Quality System Certification according to – ISO 9001 (general organisations) – ISO 13485 (Medical Devices) – Air Industries (overregulated?) Jürgen Schmitt, SES9

10. Quality Management, why do we need? Customer expectation input -> process -> output/input -> process -> Reliability Regulatory requirements – Medical Industry: FDA 21 CFR 820 (no certification) ISO 13485 – CE-Marking – Hospitals Jürgen Schmitt, SES10

11. QMS for Biomedical Engineering Does a Biomedical Engineering group need a QMS? – depends on the size of the organization – YES, if you understand the intentions and benefits of a QMS Does Biomedical Engineering group need a certified QMS? – YES, if you are responsible for the design and/or manufacturing of a medical device which is to put on the market Jürgen Schmitt, SES11

12. Industry-Academic Cooperation Medical Devices Industry is heavily regulated Medical Devices cannot be sold and used anywhere w/o registration Medical Device registration is among other requirements based on Quality Management and the respective documentation (huge effort) Medical Industry expects partners to know about QM and to comply to its requirements Jürgen Schmitt, SES12

13. Industry-Academic Cooperation Tailoring of cooperation projects Jürgen Schmitt, SES13 IdeaResearchDevelopment SpecificationDesignPrototypeField Trial Design Transfer ManufacturingSales/MarketingServicing Biomed. Eng. Industry Mixed Approach QM

14. Elements of a Quality Management System might be adapted for the research area, w/o unnecessary documentation and certification. As soon as an idea is to be turned into product to be sold, all steps from design to manufacturing need to be done according to quality system regulations with the adequate documentation. Jürgen Schmitt, SES14 Summary

15. These steps could be completed by 1.a certified Biomedical Engineering team => to get the certification is an effort of at least one year‘s work; 2.a non-certified Biomedical Engineering team => an industrial partner will have to re-engineer all your work according to the regulatory requirements; 3.a certified industrial partner; this would be quite expensive; 4.a combination of 2 & 3 Jürgen Schmitt, SES15 Summary

16. Whatever you do in the context of medical devices and procedures always imagine that the persons affected by those activities might be close and dear to you, like your parents, partners or children. With that in mind everybody will do what needs to be done in a responsible way. (Remember my little story about Everybody, Somebody, Anybody and Nobody) Thank you very much for your attention! Jürgen Schmitt, SES16