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Medical Advisor
Rebecca Beausang
MSc MDRA, ISO Auditor
Rebecca Beausang is a regulatory affairs specialist with years of experience in the medical device sector. Her expertise spans regulatory compliance in major markets, including the US, EU and Asia, and the implementation of Quality Management Systems (QMS) compliant with global standards. Rebecca excels in translating complex technical information into clear, accessible content. As an active member in TOPRA & RAPS and position as Lead Auditor, she has experience in every aspect of regulatory affairs and quality assurance. Rebecca’s contributions to enhancing medical device compliance underscores her exceptional ability in providing critical medical information effectively. Follow her on Linkedin.
Education
- Medical Device Regulatory Affairs, SETU – Waterford, Ireland
- School of Business, MTU – Cork, Ireland
- ISO Auditor Accreditation, BSI Training Academy – Cork, London, UK
Certifications
- Medical Device Regulatory Affairs (MSc)
- MDSAP Internal Quality Auditor
- ISO 13485:2016 Lead Auditor
- Bachelor of Business (B.Bus.)
Professional Accomplishments
- Post-market RA enforcement for MDR submissions
- ISO 13485 compliance of QMS design and implementation processes
- Production site QA compliance execution
- Internal auditing and engineering change analysis
- Active member and contributor to TOPRA and RAPS
Pages reviewed by Rebecca Beausang
Blood Collection System
Product Category:Blood Transfusion
Indicated Use:Hospital Supplies
A Blood Collection System is a set of sterile tools and equipment used to collect patient blood samples for medical purposes. It is manufactured by AdvaCare Pharma in ISO and CE approved facilities located in the USA, China, and India.
Blood Transfusion Set
Product Category:Blood Transfusion
A Blood Transfusion Set is a medical device used to transfer blood or blood components from one person (the donor) into another person (the recipient). It is produced by AdvaCare Pharma in ISO and CE certified facilities located in the USA, China, and India.
Central Venous Catheter (CVC) Kit
Product Category:Blood Transfusion
A Central Venous Catheter (CVC) Kit is a collection of medical devices used to insert and maintain a catheter in a large vein near the heart for prolonged venous access. It is manufactured in ISO and CE approved facilities by AdvaCare Pharma.
Hemodialysis Catheter Kit
Product Category:Blood Transfusion
A Hemodialysis Catheter Kit is a medical device used for vascular access during hemodialysis procedures. The dialysis catheter kit is manufactured by AdvaCare Pharma in ISO and CE certified facilities.
Hemodialysis Dialyzer
Product Category:Blood Transfusion
Indicated Use:Hospital Supplies
Hemodialysis Dialyzer, also called an artificial kidney, is a medical device designed to help remove waste and solutes in the blood during hemodialysis. It is produced by CE and ISO-certified manufacturer AdvaCare Pharma.
Enteral Feeding Set
Product Category:Feeding Sets
Indicated Use:Hospital Supplies
An Enteral Feeding Set is a medical device used to bring nutrition directly to the stomach or small intestine through a tube inserted into the nose, mouth, or stomach. The feeding kit is produced by AdvaCare Pharma in CE and ISO certified facilities in China, India, and the USA.