Pursuing excellence by continually monitoring, refining and perfecting our processes, we ensure we are exceeding customer expectations and consistently producing a superior product.
Quality Management System
Our Quality Management System has allowed us to obtain the following registrations:
- FDA Registered as a Contract Manufacturer and Distributor
- 21 CFR Part 820 – Quality System Regulation Compliant
- ISO 13485 Registered
- ISO 9001 Registered
- CMDCAS – Canadian Medical Device Conformity Assessment Compliant
- JPAL – Japanese Pharmaceutical Law (JPAL) compliant
The manner in which our Quality System has been developed allows our customers to leverage our system and expertise to aid in timely market entry.
Regulatory
Our experienced staff will navigate the various government and regulatory approval processes on behalf of our customers by preparing regulatory submissions for the desired markets around the globe.
- PreMarket Notifications 510(k)
- Technical Files for CE Marking
- Canadian Licenses
- JPAL Registrations
- Various Foreign Government Applications
Post Market Surveillance
Our team will aid our customers in Post Market Surveillance activities, as well. We can prepare and execute Post Market Surveillance Plans and routinely prepare reports of those activities and findings to assure state-of-the-art technologies are being used and the product is as safe and effective.