Medical Device made Easy Podcast
Technology
Medical Devices that are reusable should be cleaned. But the user is not a professional of your product so he needs to receive some instruction on how to clean it. In this episode of the podcast we will explain to you what is cleaning validation and also talk about microbiology, electrical device cleaning, Notified Body issues…
So let’s listen to Enrico Allegra from TestLabs who will share with us his experience.
Who is Enrico Allegra?Enrico has over 10 years of experience in regulatory microbiology combining environmental safety with clinical settings as a study director. He graduated with a Bachelor of Science degree in Immunology with Medical Microbiology followed by a master’s degree in Clinical Microbiology from Queen Mary University of London in 2013. During his previous role, he worked extensively in method transfer and development. His work spanned from environmental microbiology to clinical settings.
He worked on clinical trials to assess the validity of vaccination against Group B Streptococci in pregnant women.
He was strongly involved in the assessment of the safety of agrochemical products such as biocides as well as being the lead scientist for the assessment of antimicrobial susceptibility testing of pre and probiotic products. During his time working in safety assessment, he collaborated on a CRACK-IT sponsored research under the NC3Rs as the lead scientist.
The research focused on evaluating the discrimination of toxic and non-toxic chemicals using wax moth larvae Galleria mellonella as model to help reduce, replace, and refine the use of animal models.
The research was published for Chemosphere (Elsevier) in May 2018. During the height of the pandemic, he worked on the development of antiviral assays against Coronavirus as well as being part of clinical trial of bacteriophage technology to help fighting secondary infection of cystic fibrosis patients.
He is a certified biosafety officer and operates as the Head of Laboratory at Test Labs, a Medical Device testing laboratory. Enrico massively helped developing the facility from an empty canvas to a fully operational ISO 17025:2017 accredited laboratory, in less than 11 months. Leading the microbiology, chemistry and material sciences teams in performing Medical Device testing, he provides expert knowledge combining the experience in method validation and new method development to help customer with reliable and fully validated reports.
Who is Monir El Azzouzi?Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland. Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more.
Links from the VideoThe post How to perform your Cleaning Validation in practice? appeared first on Medical Device made Easy Podcast. hamza benafqir
Summative Evaluation – Common mistakes
Are you more Corrections or Corrective Actions or Preventive Actions?
How to select and evaluate your Contract Manufacturer?
Quality Field Service for Medical Devices
Medical Device NewsMAY 2024 Regulatory Update
Why and how to build a Quality Culture?
What is the impact of AI Act on Medical Devices?
Radiation Sterilisation Master File (ISO 11137 & 11607)
Medical Device News April 2024 Regulatory Update
How to benefit from Surveys to build Clinical Evidence?
How to do Postmarketing Surveillance the right way?
Learn more about FDA QMSR alignment with ISO 13485
Medical Device News March 2024 Regulatory Update
New EU Proposal – EUDAMED, IVDR & Shortage
Will EtO gaz become a Medical Device?
How to get your interview prepared?
Medical Device News february 2024 Regulatory Update
Why you should use Pre-Submission or Q-Sub with FDA?
You are not the Physical Manufacturer, can you be MDR certified?
MEDICA 2023 – InterviewS with Startups, Service Providers, Notified Bodies…
Create your
podcast in
minutes
It is Free
Insight Story: Tech Trends Unpacked
Zero-Shot
Fast Forward by Tomorrow Unlocked: Tech past, tech future
The Unbelivable Truth - Series 1 - 26 including specials and pilot
Lex Fridman Podcast