Scherdel Medtec NA Achieves ISO 13485 Certification for Enhanced Quality Standards

May 13, 2024

Setting New Benchmarks in Medical Device Quality

Muskegon, Michigan, US – April 18, 2024 – Scherdel Medtec North America, part of Scherdel Medtec GmbH, a leading global provider of medical device components, today announced it has achieved certification to the ISO 13485:2016 standard. This internationally recognized standard outlines the requirements for a quality management system (QMS) specific to the medical device industry.

“Achieving ISO 13485 certification is a significant milestone for Scherdel Medtec North America,” said Drew Jelgerhuis, Business Development Manager. “This accomplishment underscores our unwavering commitment to providing our customers with the highest quality and safest medical device components possible.”


The path to certification began two years ago as a key objective within the strategic plan. The groundwork was laid by Grace Piasecki, Quality Management, who focused on ISO 13485 requirements, writing the quality management system and implementation plans. Her dedication and collaboration with Scherdel Medtec headquarters and international teams in Germany and France were instrumental in securing this important accreditation. The multi-disciplinary team including quality, logistics, engineering, production, project management, and human resources were all committed to executing the best management system and its implementation across all disciplines.


“We are confident that ISO 13485 certification will provide several key benefits for Scherdel Medtec NA and our customers,” said Jelgerhuis. These benefits include:

  • Stronger Foundation: ISO 13485 establishes a QMS specifically designed for the medical device industry, providing a solid foundation for continued growth in North America.
  • Enhanced Customer Confidence: Certification demonstrates our commitment to quality and safety, assuring customers that the medical device components they rely on meet the highest
    standards.
  • Expanded Market Access: As the value of ISO 13485 certification continues to rise within the medical device market, Scherdel Medtec NA is positioned to meet the growing requirements of
    drug, device, and contract manufacturers.
  • Risk Reduction: A well-implemented ISO 13485 QMS helps identify and mitigate potential risks before they impact medical devices.
  • Improved Efficiency: Streamlined processes and reduced waste contribute to increased efficiency and productivity.
  • Employee Engagement: A culture of quality and safety fosters a more motivated and engaged workforce, leading to improved performance.


About Scherdel Medtec
Scherdel Medtec is a leading provider of high-precision medical device components, offering a comprehensive portfolio of solutions for complex medical device applications. Scherdel Medtec is committed to delivering the highest quality products and services to its customers, ensuring patient safety and improving healthcare outcomes.

RECENT ARTICLES

MichBio Hiring: Intern, Association Membership & Resource Analytics

April 15, 2025
MichBio seeks a highly motivated individual who can work creatively in a small team environment and assist in data mining, compilation, and research.

Bio Survey Underscores Impacts of Tariffs for Businesses

April 11, 2025
The Biotechnology Innovation Organization (BIO), of which MichBio is a state affiliate recently released the results of a survey of its members, noting that “U.S. Biotechs Sound the Alarm” on tariff impacts. The findings include: Tariffs on European Union and Canadian imports would increase manufacturing costs for 94% and 82% of biotech firms, respectively. 70% of companies anticipate higher manufacturing costs due to tariffs on China. Tariffs on the European Union would force 50% of biotech firms to identify new research and manufacturing partners. More than 50% of biotech firms predict “increased difficulty” in funding and conducting research if EU tariffs are enacted. 80% of biotech firms would need at least 12 months to find alternative suppliers; 44% would need over two years. The survey noted that sudden tariffs would fundamentally punish American companies, threaten vital research projects and imperil United States leadership in biomedical science. Read BIO’s press release , along with an one-pager summarizing the survey results. 

Amid Proposed Cuts, Commission Calls For $15B NIH Support

April 10, 2025
A federal commission, in a new report , is calling for $15 billion in new financing to reinforce the United States’ biotech leadership amid encroaching competition from China. This comes against a backdrop where the Trump Administration has proposed severe cuts to NIH operations and funding. The National Security Commission on Emerging Biotechnology was created by Congress in 2022 to explore how biotechnology advancements could shape the economy and national security. The body quickly focused on China, as that government has gone about gathering Americans’ genetic information and intellectual property in the biotech space and resourcing their cluster’s rapid growth. The report’s 49 recommendations, organized across six strategic pillars, offer a bold and actionable framework to protect U.S. biotech intellectual property and bolster drug development, agriculture, and biological weapons defense: Prioritize biotechnology at the national level Mobilize the private sector to get U.S. products to scale Maximize the benefits of biotechnology for defense Out-innovate our strategic competitors Build the biotechnology workforce of the future Mobilize the collective strengths of our allies and partners The report calls for $1 billion to create an investment fund, more than $6 billion for large-scale research challenges, and a build-up of biomanufacturing sites across the country. Also, it calls for new legislation barring companies that work with U.S. national security agencies or health agencies from using certain Chinese biotech suppliers. The commission doesn’t have the power to authorize any changes but can make recommendations and advise members of Congress. BIO issued a statement in support.