QAL’s compliance with ISO standards and FDA regulations benefits both our company and yours (Food and Drug Administration (FDA) 21CFR 820 –Code of Federal Regulations Title 21).
QAL’s compliance with FDA 21 CFR 820 guarantees that finished devices will be safe and effective and otherwise, in compliance with the Federal Food, Drug, and Cosmetic Act
Quality & Reliability
QAL maintains ISO 13485 certification and is compliant to 21 CFR 820 to guarantee the highest standards of quality, repeatability and safety for our customers. Our compliance with ISO and FDA regulations benefits both our company and yours.
Optimizing our production capabilities and following strict quality standards set forth by ISO 13485 and 21 CFR 820, our manufacturing expertise is passed on to you, resulting in a high quality, safe and dependable product that complies with your specifications.
A Track Record You Can Count On
We stand above our competition by consistently complying with standards and improving our processes. We are able to obtain and maintain certification with the world’s most rigorous standardizing organizations, which includes the International Organization for Standardization and other regulatory bodies like European Medical Devices Directive (MDD) and Canadian Medical Devices Conformity Assessment System (CMDCAS).
Certifications and Compliance:
- Products we manufacture continue to meet or exceed the minimum requirements of product safety standards.
- Our production facility conforms to a wide range of compliance and quality standards and regulations.
FDA (21 CFR 820)
ETL = Electronic Testing Laboratory
UL = Underwriters Laboratory
CE = Conformité Européene
FM = Factory Mutual
CSA = Canadian Safety Administration
JPAL = Japan’s Pharmaceutical Administration Laws
(RoHS) compliant = Restriction of Hazardous Substances