Regulatory Affairs

ConceptDesign & DevelopmentVerification and ValidationRegulatoryQMSProduct Launch

 

Our experts at JALEX Medical will assist you in meeting every standard and regulation to secure your pathway of commercial success.

Regulatory Pathway and Product Classifications

Properly classifying your device is critical.  JALEX Medical can help you develop regulatory strategies and pathways for your Class I or II medical device. Our experts know how to navigate the FDA and international regulations to get you through the process efficiently.

510(k) Submissions

JALEX Medical has proven success with writing Traditional, Special, and Abbreviated 510(k) submissions. The team’s experience and knowledge keep us at the forefront of all regulations while generating your documentation.

Unique Device Identification (UDI)

JALEX Medical will help you understand the UDI requirements for your device. Class II and III devices already require UDI compliance, and all Class I and unclassified devices require UDI on labels and data submitted to FDA by September, 2020. We can develop processes for identifying and submitting data to the FDA’s Global Unique Device Identification Database (GUDID) and provide training for all essential UDI activities.

Registration and Listings

Prior to marketing a product, your device needs to be listed with the FDA. We make it easy to go through the process to get your establishment registered and device listed by providing explicit instructions and ensuring you are under the correct establishment and fee structure.

Post-Launch Regulatory Support

JALEX Medical is also your resource for post-market activities. The team can help you respond to any FDA compliance issue.

  • 483 Observation responses
  • Warning letters
  • Untitled Letters
  • Consent decree remediation

International Regulatory Affairs

If you are looking to enter an international market, JALEX Medical can assist you with understanding the regulations, classifications, and other requirements for the European (CE Mark) and Canadian (Health Canada) markets.


Get Started on Regulatory Affairs with JALEX by Filling out the Form Below

 

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