Celebrating a Milestone: We’re Recertified in ISO 9001:2015 and ISO 13485:2021!
- epacbv
- Jun 3
- 2 min read
We’re proud to announce that we have successfully achieved recertification in ISO 9001:2015 and ISO 13485:2021—a significant milestone that reaffirms our unwavering commitment to quality, compliance, and customer satisfaction.
This achievement underscores our dedication to delivering consistently high standards in everything we do—from internal processes to the products and services we provide.
What Do These Certifications Mean?
ISO 9001:2015 is a globally recognized standard for quality management systems (QMS). It ensures organizations can reliably meet customer expectations while complying with applicable regulations.
ISO 13485:2021 is tailored specifically for the medical device industry, setting rigorous requirements for the design, production, and servicing of medical products to ensure safety and effectiveness.
A Clean Recertification—No Remarks or Observations
One of the most rewarding aspects of this recertification is that both standards were passed with zero remarks or observations. This “clean bill of health” is a testament to the diligence, discipline, and teamwork across our organization.
Our team’s hard work ensures our processes and documentation consistently meet the highest industry benchmarks. It’s a source of pride—and it builds trust with our clients, stakeholders, and partners.


What This Means for You—Our Customers and Partners
For our customers, this recertification is more than just a badge—it’s a promise. A promise that we:
✅ Prioritize quality in every product and service
✅ Meet and exceed regulatory requirements
✅ Remain dedicated to continuous improvement
This achievement also opens new doors to collaborative opportunities, particularly with partners who value robust quality systems as much as we do.
Thank You
To our incredible team: thank you for making this possible. Your commitment to excellence is what drives our success and sets us apart.
To our customers and partners: thank you for your continued trust. We look forward to reaching even greater heights—together.
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