Regulatory Compliance
Compliance to agency and regulatory requirements of the consumer, industrial or medical industries, from gap analysis through testing.
•ISO 13485 certified through TUV
•FDA compliance to FDA 21 CFR 820
•Development process designed to Class l, ll and III medical device standards
•ISO 9001 compliant
•FCC certifications of module and chip down designs
•Bio-compatibility and toxicology testing management, including sample creation and testing process validation
•Full EMC compliance consulting and testing management from preliminary testing through full certification
•Agency submission support and certification services start to finish - UL - MECA - CSA - ETL - others
•60601-1 gap analysis and compliance services
Case Studies
