Quality and Regulatory

In a dynamic environment where meeting and staying compliant with quality and regulatory requirements present constant challenges, Ximedica offers a proven solution. We can smooth out often arduous processes with top-to-bottom capability.

 

Quality services include:

 

• General inspections

• First-article inspections

• Failure analysis

• Design verification testing

• Test protocol generation

Regulatory services include:

 

• Plan and create a company quality system

• Audit an existing quality system

• Review regulatory documents Implement QSR system

• Implement ISO 13485 process

• Conduct site audits

• Conduct advisory reviews and planning

• Conduct regulatory strategy planning

• Manage 510(k) and PMA submissions