Quality Systems

ConceptDesign & DevelopmentVerification and ValidationRegulatoryQMSProduct Launch

 

A robust and compliant quality system is the backbone of every medical device company. It ensures your company will consistently provide safe and effective products for use. Each company has specific business needs that a quality system should be tailored to. 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. Our team will work with you to either create a quality management system or provide a gap analysis to your current system to identify areas that need improvement or compliance updates.

Develop, Implement, and Train

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

Short on resources for your product launch? JALEX Medical can serve as your quality department as you ramp up production and enter the medical device market.

Audit

When a regulatory agency conducts an audit, you can count on us to step in with the answers. 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 1271 Human Cells, Tissues, and Cellular and Tissue-based Products
  • FDA 21 CFR 600 Biological Products
  • ISO 13485: Medical devices - Quality management systems - Requirements for regulatory purposes
  • ISO 9001: Quality management

We also assist with supplier audits to ensure your vendors are providing quality products and services per your specifications.
 

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 ensure your product is safe and effective for its intended use. Our team will help from the initial assessment to managing risks associated with post-market changes. We provide the expertise to make sure you make informed decisions with patient safety in mind.


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