Production & Quality

Download our ISO 13485 Certificate here.

FDA Registered and ISO Certified.

WHK is FDA Registered as a Medical Device Manufacturer and is ISO 13485 Certified.  

Our Quality Management System exceeds FDA Quality System Regulations (cGMP), and includes:

  • Qualification of all suppliers
  • Supplier Quality Agreements 
  • Raw material and component sourcing, certification & regulatory compliance
  • Equipment and tooling IQ, OQ and PQ
  • Lot traceability for material and labor, from receiving to shipping
  • Material review board
  • Internal/external auditing 
  • Environmental particulate and microbial monitoring  
  • Risk assessment and mitigation for raw components & manufacturing processes
  • Assistance with filing 520(k)'s, Drug Master File, and Material Master File
  • Manage and oversee gamma irradiation and sterilization 
  • Product stability and leak testing
  • Acceptance quality levels based on ANSI/ASQ Z1.4
  • FDA Pharmaceutical packaging requirements

For More Information:  Contact Customer Service at 855-WHK-BIO1 (855-945-2461) or 727-209-8400 or E-Mail Us Here.