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Quality and Compliance

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Industry Standards

ISO 13485: Certified to Deliver

cGMP: Living Compliance Daily

Traceability and Documentation

Validation You Can Count On

Quality That Stands Up to Scrutiny

Audit-ready, validation-flexible, and built on decades of experience in regulated environments.

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A System You Can Trust

Clean, Controlled, Committed

We fully align with cGMP, ensuring cleanliness, control, and traceability throughout production. Continuous improvement drives everything we do, from real-time monitoring to operator feedback. With a 99% supplier quality rate, we control risk at every stage and evolve our systems to stay ahead. We train staff to think proactively, act transparently, and own their impact because we don’t just follow best practices, we evolve them.

Framework Current Good Manufacturing Practices (cGMP)
Supplier Quality Rate 99%—driven by strong vendor qualification and inspection
Continuous Improvement Lean teams, operator input, process validation
Automation & Tools CAD/CAM, robotics, SPC
Traceability ERP-managed lot control, tooling, and parameter tracking
Why It Matters Fewer defects, better audits, and long-term manufacturing reliability

Built for Clarity, Built for Control

Every component and process at BMP Medical is fully traceable—from raw materials to inspection results. We use serialized lot control through our ERP system, apply UDI where required, and maintain audit-ready documentation within our electronic QMS. Good Documentation Practices (GDP) guide every record we generate, because traceability builds trust.

UDI Applied where applicable for regulatory tracking
ERP Integration Serialized lot-level control for every batch
Electronic QMS Centralized, validated, and always audit-ready
GDP Compliance Ensures consistency, accuracy, and traceable records
Why It Matters Reliable part history, faster audits, and confident decision-making—for us and our partners

IQ/OQ/PQ Built to Mitigate Risk

Our validation process ensures repeatability, quality, and safety long before production begins. We apply robust IQ, OQ, and PQ protocols to confirm each process is installed correctly, performs within range, and produces consistent results. Every phase is fully documented, reviewed, and resolved, reducing risk for our customers and the patients they serve.

IQ Verifies installation against design and manufacturer specs
OQ Tests performance under low, nominal, and high conditions
PQ Demonstrates consistent output under real production use
Data Integrity All steps analyzed, reported, and signed off
Why It Matters Validated, low-risk processes that meet specifications and build confidence across project teams