Supporting Medical Device Customers with ISO 13485 Certification

Supporting Medical Device Customers with ISO 13485 Certification

Posted on: April 8, 2020

SEACOMP now serves our medical customers better with our recently awarded ISO 13485 certification. The ISO 13485:2016 standard pertains to the quality management systems in place specific to medical devices which ensures customer and regulatory requirements are consistently met at the highest level of quality.

ISO 13485:2016 logoThe certificate states that our manufacturing facility’s management system conforms to the requirements of ISO 13485. It is applicable to:

  • The design, development and manufacture of power supplies for medical devices
  • The manufacture of stimulators and heart rate monitors
  • The manufacture of PCBAs for medical devices

Michael Szymanski, CEO of SEACOMP, states, “At SEACOMP, our vision is to ‘improve the world we live in by making great ideas into great products.’ Our emergence as a key supplier to the medical industry is at the forefront of that vision.”

Szymanski continues, “Across the past 5 quarters, more than a third of our new programs have been for medical products. The completion of the ISO 13485 certification this last month will continue to build confidence with our key partners that we are committed to the industry. I am incredibly proud of our amazing team for this achievement.”

We worked with global accrediting body Intertek to ensure our quality management system fulfills the regulations set by the medical device industry. Our audit process was then completed in December 2019.

It was a smooth and successful audit due to our dedicated team led by SEACOMP Quality Manager, Andy Liu. “Our fantastic team worked to make it happen - we are committed to providing better products and services,” comments Liu.

The strict regulatory requirements set by the medical industry affects every step of the medical device’s lifecycle. ISO 13485:2016 certification demonstrates that SEACOMP is committed to fulfilling those requirements to better serve our customers.

“SEACOMP endeavors not simply to meet our clients expectations but to exceed them,” adds John MacVicar, VP Manufacturing. “As a result, we are truly a 'quality-oriented organization' and we work hard to improve our level of service each year. We use our quality management system, certified not only to ISO 9001:2015 but also to ISO 13485:2016, as a key driver to enable our dedicated team for ongoing process improvement and commitment to the customer."

MacVicar concludes, "We want to make satisfied customers even happier with their next project.”

Contact SEACOMP, an ISO 13485 certified manufacturing partner, today to discuss your medical device manufacturing needs.