Advancing Quality And Regulatory Readiness: Building Trust At Silcotech

At Silcotech North America Inc., quality is central to the trust our customers place in us. We continue to strengthen that foundation through our quality management systems, independent certification, and preparation for the regulatory requirements that matter to our customers.

In Q3 2026, Silcotech transitioned its certification body from NSF to UL Solutions, which now holds our current ISO 9001 and ISO 13485 certifications. ISO 9001 supports consistent processes, customer satisfaction, and continuous improvement, while ISO 13485 addresses quality management requirements specific to the medical device industry. These standards provide a framework for maintaining a disciplined approach to quality and meeting applicable customer and regulatory requirements.

Building on this foundation, we are working toward certification under the Medical Device Single Audit Program (MDSAP), with certification expected by the end of 2026. MDSAP allows a recognized auditing organization to conduct a single audit that addresses the relevant requirements of multiple participating regulatory authorities. For Silcotech, pursuing this certification is an important step in strengthening our quality assurance program and supporting customers operating across international medical device markets.

Looking ahead, we are targeting completion of our European Union Medical Device Regulation (EU MDR) implementation by Q2 2027. The EU MDR establishes a regulatory framework focused on medical device safety, transparency, and traceability. Our implementation work is intended to align relevant processes with applicable requirements and strengthen our readiness to support customers with European medical device programs.

For our customers, these initiatives reflect our continued focus on dependable manufacturing, clear quality expectations, and long-term partnerships. As medical device projects progress and requirements develop, we want our quality systems to provide a strong foundation for the work we undertake together.

Thank you to our Quality Assurance team and colleagues across Silcotech for the attention to detail, collaboration, and commitment to continuous improvement that drive this work forward.