A half-day seminar focusing on current regulatory expectations in the validation of reusable medical devices is the subject of a seminar that will be held on Dec. 4, 2013 in Waltham, Mass.
The validation of reusable medical devices is at the forefront of the FDAs efforts to ensure patient safety. Requirements for the cleaning, disinfection, and sterilization of reusable devices are constantly changing. The situation challenges manufacturers both in terms of deciding which testing methods to employ as well as the planning if end points.
The seminar will provide attendees with the knowledge they need to know about current regulatory expectations so they may better prepare their submissions for FDA acceptance and avoid the time-consuming and costly requirements of additional testing.
Seminar topics will include:
- Discussion of the FDAs draft guidance for industry and FDA staff, Processing/ Preprocessing Medical Devices in Healthcare Settings
- Methods used for the cleaning and validation of reusable devices
- Methods for the disinfection of reusable devices
- Methods for the sterilization of reusable devices
- Testing requirements
- Detailed discussion of endpoints for cleaning validation
The seminar will be presented by Microtest Laboratories, a leader in testing services and contract manufacturing for the medical device, pharmaceutical, and biotechnology industries, on Wednesday, Dec. 4, 2013, from 9 a.m. to 1 p.m. at the Conference Center at Waltham Woods in Waltham, Mass., just outside Boston. Registration is at 9 a.m. A continental breakfast, break refreshments, and a luncheon are included.
Source: Microtest Laboratories