Research von relevanten Medical-Normen für Kunststoffteile

Plastic parts play a central role in medical technology, from disposable products to complex implants. They must comply with strict medical standards and regulatory requirements to ensure safety and quality. These standards include, for example, ISO standards, FDA specifications and European medical device regulations.

The aim of this Bachelor's thesis is to systematically analyse the relevant standards for plastic components in the medical sector and to present them in an overview.

Job description:

• Identification and compilation of the relevant international standards (e.g. ISO 10993, ISO 13485, MDR 2017/745, FDA requirements)
• Analysis of the requirements for material properties, biocompatibility and sterilisation
• Comparison of requirements in different markets (EU, USA, Asia)
• Evaluation of the impact on product development and authorisation
• Creation of a practice-orientated guideline for manufacturers
• Expert interviews with medical device manufacturers or regulatory affairs specialists
• Analysis of case studies of successful approval processes
• Presentation of the standards in a comparison scheme for quick application

Job requirements:

• Student: in Medical/Plastics Engineering, Industrial Engineering, Regulatory Affairs or similar degree programmes
• Analytical thought process
• Structured approach
• Competence in dealing with Microsoft Office
• Team and communication skills