Reprocessing Reusable Medical Devices - Cleaning & Labeling Requirements - validations

This Medical device training will explain the regulatory requirements including cleaning and sterilization methods & validations.

However, there are also FDA requirements for reprocessing reusable medical devices. Most class II medical devices & even a few class I medical devices require 510(k) clearances before marketing them. When manufacturers submit 510(k)’s, they typically follow FDA guidance documents written for specific types of devices. Similar requirements can be found in European Union CE marking requirements. Hospitals & clinics have been steadily increasing their demands for detailed, written directions for processing reusable medical devices, regardless of the classification. This presentation will discuss these requirements.

Areas Covered in the seminar:

• Regulatory requirements
• European Union requirements
• Guidance documents
• International standards
• Cleaning & sterilization methods
• Cleaning & sterilization validation

Who Will Benefit:

Manufacturers of reusable medical devices need to be aware of the requirements for reprocessing reusable medical devices, since both the FDA and the users will be asking for detailed reprocessing instructions. This Webinar will explain the regulatory requirements including cleaning and sterilization methods & validations. Some employees who wish to gain a better understanding include:

• Quality & Regulatory Professionals
• Manufacturing & Design Engineers
• Marketing Product Managers
• Hospital risk management groups