Scherdel Medtec – An Intern’s Perspective

By Grace Piasecki

As a junior studying Biomedical Engineering at Grand Valley State University, gaining experience is a key factor to becoming a successful engineer. Scherdel Medtec has given me the opportunity to gain that experience.

 

Focusing on ISO 13485, an international standard regarding quality management system requirements for medical device organizations, I was able to provide recommendations for the future of Scherdel Medtec’s quality management system to get certified in ISO 13485.

Being able to play a role in building the ISO 13485 project from the ground up has been an incredible opportunity. I was given full discretion to research, structure, and conduct a gap analysis for the ISO 13485 standard.

The beginning of the internship involved reading the standard and multiple field guides, shadowing the quality team, meeting with members of the Medtec team from Germany, and researching additional information to get familiar with the standard requirements.

With my knowledge, I was able to independently perform a gap analysis and create an implementation guide for the company based off of the gap analysis findings. I scheduled and conducted meetings to learn about processes of the quality system and created additional resources that helped me in the research in learning the ISO standard which will be beneficial for the future of the company.

 

    I was also given the opportunity to go on benchmark visits with the Scherdel Medtec team. These benchmark visits provided me with more information for my project and understanding on how the medical device industry works.

    The Scherdel Medtec team has not only provided me with knowledge for my career but have also taken their “We Care” approach to another level. From meaningful conversations and advice, they always make sure I am taken care of and am given all the resources I need to be successful. They have given me valuable networking opportunities, including attending MiDevice meetings, a medical device organization for West Michigan. The impact that they have left on me has been significant and will help me in my engineering career.

    As a biomedical engineering student, gaining experience can be difficult, but Scherdel Medtec has succeeded in helping me acquire my newfound knowledge in the medical device industry.

     

    Images courtesy of Grace Piasecki 

     

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