216.307.6299   info@jalexmedical.com

Device Design, Regulatory Affairs, Quality Systems

Device

Design

Regulatory

Affairs

Quality

Systems

Regulatory Affairs

“The JALEX team is great at putting things in terms I can understand and assisting me in navigating the FDA requirements.”

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, II or III medical device. Our experts know how to navigate the FDA and can get you through the process quickly and efficiently.

 

510(k) Submissions

JALEX Medical has proven success with writing Traditional, Special, or Abbreviated 510(k) submissions. The team’s experience and knowledge keeps 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 2018. 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 issues.

     • 483 Observation responses

     • Warning 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.

– Medical Device Company, Ohio

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