Quality and Regulatory
Panacis designs its products to pass stringent international regulatory requirements and works with necessary agencies to get them approved. Design and production is supported by certified quality systems.
Regulatory Approvals
At Panacis, we have extensive experience in the design of products for regulatory approval and product markings. This experience translates in to time and cost savings for our customers, who see their product designs successfully and quickly pass through regulatory approvals. Moreover, our understanding of how regulations can constrain designs means that our products are designed the right way the first time. We work closely with our clients and with regulatory agencies to ensure timely and low-risk approvals.
- Product Safety and Performance: including, but not limited to CSA, CE, UL, MET and FCC
- Medical Device Approvals to Market: Canada, US, Europe, Australia, South America and others
- Battery Safety, including UN, UL and CSA directives and approvals
Panacis Quality Systems
For programs that require it, design and production at Panacis is compliant with our ISO-inspired quality systems. Panacis is an internationally registered manufacturer of medical devices that require development and manufacture under an ISO 13485 certified quality system. Our approved medical products ship around the world. We are currently in the process of establishing an AS 9000 system to better support our partners in the defense and aerospace sectors.
