Olson Custom Designs Blog

Olson Custom Designs Achieves ISO 13485:2016 Certification, Reinforcing Commitment to Medical Device Manufacturing

Written by Olson Custom Designs | Aug 5, 2024 4:28:30 PM

[Indianapolis, Aug 5, 2024] – We're excited to share that Olson Custom Designs (OCD) has achieved ISO 13485:2016 certification! This milestone highlights our dedication to excellence in the medical device manufacturing sector. Along with our existing ISO 9001:2015 and AS9100D certifications, it showcases our commitment to delivering the highest quality standards for our customers as a scalable contract machine shop for critical components.

"Achieving ISO 13485:2016 truly sets us apart from many other contract machine shops," said Mitch Olson, President of Olson Custom Designs. "It assures our partners that we'll consistently meet their rigorous quality and regulatory requirements. We continue to grow our capabilities along with having doubled our machining capacity in only 18 months. Our desire is to grow with our customers, and we pride ourselves on an unmatched standard of excellence."

Over the last decade, we’ve helped grow life-critical medical device manufacturing for our clients. From first article to full rate production volumes, we guide our clients every step of the way. And if needed, we’ll invest in new machine capacity alongside them. Our team is all about scalable contract manufacturing for your critical components, driven by quality people and processes.

Why choose Olson Custom Designs?

  • Reliable and Responsive: We deliver on time and to spec. We can prove it.
  • Transparent Communication: We always keep you in the loop, even when it's bad news.
  • Customer-Centric Approach: We’re driven to not let our customers down.
  • Detailed Planning and Project Management: We manage the details, so you never have to worry.

We’re celebrating our 10-year anniversary this year, and we’re proud to be a trusted partner for so many top companies in the Aerospace/Space, Defense and Medical markets. Our comprehensive approach ensures reliable results and fosters long-term partnerships with our clients.

Have questions or want to learn more? You can find us at OlsonCustomDesigns.com or reach out directly to us at gabe@ocdfab.com. We're here to help!