Reprocessing Reusable Medical Devices - Cleaning and Labeling Requirements

Website http://www.traininng.com/webinar/reprocessing-reusable-medical-devices---cleaning-and-labeling-requi | Edit Freely

Category Healthcare, technology, pharmaceuticals,medical courses, online trainings, 2019 trainings

Deadline: April 02, 2019 | Date: April 04, 2019

Venue/Country: Online, U.S.A

Updated: 2019-03-13 18:54:50 (GMT+9)

Call For Papers - CFP

This training program will explain the rationale, the legal requirements and some methods commonly used for reprocessing and validating reusable medical devices.

Why should you Attend

Any firm reprocessing another manufacturer's medical device becomes the legal manufacturer with all the responsibilities for compliance, especially sterility.

Failure to prove sterility is almost certainly a cause for either voluntary recall or FDA mandated recall. The same is true if you are reprocessing your own medical device. If intended to be re-sterilized by the user facility, cleaning and sterilization instructions must be precise and validated. Much attention has been paid to the regulatory requirements of reprocessing single use devices.

However, there is increasing attention being directed towards reprocessing reusable medical devices and regulatory requirements.

The purpose of this webinar is to explain the rationale, the legal requirements and some methods commonly used for reprocessing and validating reusable medical devices.

Areas Covered in the Session

Reasoning behind labeling requirements

Regulatory requirements

Intended use and design

Standards/guidance

Validating cleaning and sterilization

Who Will Benefit

Design Engineers

QA Managers

Quality Engineers

Regulatory Affairs Managers

Manufacturing Engineers

Hospital Operating Room Nurse Supervisors

Speaker Profile

John Chapman, BS, MBA, RAC has over 35 years medical device regulatory & compliance experience and over 15 years experience with the European Union's medical device directive, 93/42/EEC. John has led two device companies to ISO quality system certification and CE marking.