216.307.6299   info@jalexmedical.com

Device Design, Regulatory Affairs, Quality Systems







Quality Systems

JALEX Medical will assist you in defining your quality objectives and developing the policies, procedures and processes to achieve and maintain them in an efficient manner.


Develop, Implement and Train

The experts at JALEX Medical will write standard operating procedures and document controls. We also train you and your team members for compliance with the FDA Quality System Regulations (QSR) and ISO 13485.



When a regulatory agency conducts an audit, you can count on us to step in with the answers. One of our specialized JALEX Medical team members will accompany you during audits by regulatory and third party auditors. We provide compliance auditing for the following regulations:

  • FDA 21 CFR 820 Quality System Regulation
  • FDA 21 CFR 210  Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs
  • FDA 21 CFR 211 Current Good Manufacturing Practice for Finished Pharmaceuticals
  • ISO 13485
  • ISO 9001


Assess and Manage Risk

Risk management can be the most critical part of medical device development. We provide rigorous risk management procedures and training tools to make sure your product is safe and effective for its intended use.

“JALEX Medical’s comprehensive service continues through educating us on, and designing our quality system.”

– Medical Device Company, Florida

© 2017    JALEX Medical LLC.    P. 216.307.6299    30311 Clemens Rd. #5D Westlake, OH 44145