Why you should use Pre-Submission or Q-Sub with FDA?
We always have a problem to contact regulators to ask them if our strategy is correct. In Europe, you cannot do that with a Notified Body unless you apply with one first and they cannot provide you with advice but just agree or disagree on your plan. Is it the same with the FDA. They have a specific pathway called Q-sub or Pre-Submission and you’ll see that this may be your Superpower to accelerate your success with your FDA application. Let’s listen to Saad Attiyah who will explain what is Q-SUB.
Who is Saad Attiyah?
Experienced Regulatory Affairs and Quality Assurance professional with 20+ years of experience in medical devices, in-vitro diagnostics, human/cell tissue products, and combination device/drug products. Proven experience with U.S., Canadian, and E.U. Regulators, submissions, and Global Strategy Development. Extensive experience authoring U.S. 510(k)’s, E.U. MDR Technical Documentation, HDE Supplement, HDE/PMA Change Assessments for Supplements, Letters to File, Q-Submission, and Canadian New Submission/Amendments. Certified Lead Auditor, QMS Expert, and Warning Letter Remediation.
Areas of specialty: New Product Development Strategy for Global Markets, Maintenance and remediation of existing devices, clinical evaluation reports/trials, and compliance activities, QA/QC, SOP development.
Device Types: Capital equipment and consumables such as blood analyzers and reagents, sterilizers and sterilant, ventilators, aspirators, centrifuges, implantable devices, single use medical devices, reusable instruments, and thermometry devices.
Device Classifications: US I through III, Canada Class II through IV, E.U. Class I through Class III, Compassionate Use
510(k): K072866-Spinal Fixation System, K080281- Interbody Fusion Device, K090566- Novel Interbody Fusion Device, K091134- Anterior Cervical Plating, K092904 -Vertebral Body Replacement Device, K111009- Spinal Fixation System, K111774- Interbody Fusion Device, K153379- Orthopedic Plating, K161863- Shoulder Arthroplasty Devices w/expanded indications, K181091- Orthopedic Plating w/ Pediatric Indications.
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.
- Saad Attiyah LinkedIn: https://www.linkedin.com/in/saadattiyah
- US FDA QSUB guidance : https://www.fda.gov/regulatory-information/search-fda-guidance-documents/requests-feedback-and-meetings-medical-device-submissions-q-submission-program