Lake Region Medical's commitment to quality ensures that its products and services meet or exceed the highest standards set by the United States Food and Drug Administration, the European Community and other internationally recognized agencies.
Lake Region Medical has established an industry-wide reputation as an award-winning supplier with high quality standards through enforcement of stringent design and inspection requirements. This provides customers with the added security in knowing that the most sophisticated quality requirements are inherent in all aspects of Lake Region Medical's business practices.
Key Capabilities Include:
Packaging and distribution via ISTA and ASTM standards
Design controls and ISO 14971 (risk management)
ISO 13485 quality management system
Japanese PMDA compliant for
device design & manufacturing