Insights into the validation process for cleaning medical devices

Have you ever had to deal with Cleaning Validation. If yes than you know the pain to select the instruments and group them and for each group find a worst case. On this episode, we tell you how this should be working so you can guarantee to provide clean products and clean instructions to your customers.
-----------------------------------------------------------------------------------------------------------------------------
► Who is Heena Thakkar?
Heena Thakkar is a regulatory consultant currently working with Alceon Medtech Consulting. She is based in Gujarat, India. Heena is qualified in risk management, design controls, usability engineering, clinical evaluation, clinical trial management, quality management systems and process validation. She is also a certified internal auditor.
Heena has around 8 years of experience in the field of regulatory affairs and quality management system for medical devices. She is experienced in regulatory submissions for vast range of devices ranging from orthopaedic devices, endovascular devices, single-use consumables, ophthalmic devices and wound care devices. She also conducts external trainings in the areas such as risk management, quality management system, EU MDR and EU IVDR.
-----------------------------------------------------------------------------------------------------------------------------
► Who is Monir El Azzouzi?
Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies, particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people better understand Medical Device Regulations worldwide. He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses… His company also acts as Authorized Representative for the EU, UK, and Switzerland. Easy Medical Device becomes a one-stop shop for medical device manufacturers that need support on Quality and Regulatory Affairs.
--------------------------------------------------------------------------------------------
► Links from the Video
Heena Thakkar Linkedin Profile:
www.linkedin.com/in/heenathak...
Alceon Medtech Consulting Website:
alceonconsulting.com
List of standards helpful for cleaning validation of reusable instruments
ANSI/ AAMI ST98: Cleaning validation of health care products-Requirements for development and validation of a cleaning process for medical devices www.aami.org/standards/featur...
USFDA Guidance: Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling (www.fda.gov/media/80265/download)
ISO 17664-1:2021: Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 1: Critical and semi-critical medical devices (www.iso.org/standard/81720.html)
ISO 15883-1:2006: Washer-disinfectors - Part 1: General requirements, terms and definitions and tests (www.iso.org/standard/41076.html)
ISO 15883-5:2021: Washer-disinfectors - Part 5: Performance requirements and test method criteria for demonstrating cleaning efficacy (www.iso.org/standard/68297.html)
ASTM F3208-20: Standard Guide for Selecting Test Soils for Validation of Cleaning Methods for Reusable Medical Devices (www.astm.org/f3208-20.html)
ASTM F3293-18: Standard Guide for Application of Test Soils for the Validation of Cleaning Methods for Reusable Medical Devices (www.astm.org/f3293-18.html)
There are many additional standards that manufacturers will need to refer to in addition to the ones listed above. Contact us at [e-mail] for additional information or service inquiry. Thank you!
-------------------------------------------------------------------------------------------
► Social Media to follow
■ Monir El Azzouzi Linkedin: / melazzouzi
■ Twitter: / elazzouzim
■ Pinterest: / easymedicaldevice
■ Instagram: / easymedicaldevice
------------------------------------------------------------------------------------------
#easymedicaldevice #medicaldevice #regulatorycompliance

[@EasyMedicalDevice]

For full episode check:ua-cam.com/video/ebC1O2g_ac8/v-deo.html