Risk Mitigation
Dukal InSure™
Reduce operational complexity and put our expertise to work with Dukal’s Quality and Regulatory System.
Overview
Dukal InSure™ combines Dukal’s industry-leading knowledge of quality and regulatory compliance requirements and our experienced global team to help you navigate the complexities of healthcare operations.
Benefits
We ensure there are no gaps in the quality and regulatory requirements that could result in delays, fines, or lost product.
Contain costs
Our operational process and insights help you make informed decisions to contain costs by improving efficiencies, reducing waste, and avoiding costly fines, legal fees, and product recalls.
Maintain compliance
Ensure safety, compliance, and continued certification amid a constantly evolving regulatory landscape with a trusted partner.
Satisfy customers
With the increased competition in today’s market, it is imperative to consistently deliver a quality product that meets or exceeds customer expectations.
Industry leading knowledge of quality and regulatory compliance
continues to differentiate us
Our experienced global team ensures product compliance and specification requirements to protect the value of your brand.
Certifications
ASQ Certified Quality Auditor
PMI Certified Project Manager
MDSAP (Canadian, Australian, Japanese, and Brazilian regulations)
EU MDR
ISO 13485
ISO 9001
ISO 17025
ISO 11135
ISO 11137
ISO 14971
FDA 510(k)
C-TPAT
QSR/QSIT
21 CFR 820, 210, 211
Lean Six Sigma Green Belt
Case Studies and Articles
Resources
Take the Next Step
Get started quickly with a risk mitigation strategy briefing.
Discover where Dukal InSure™ can make the biggest impact
and how you can elevate your business with Dukal.