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- Rebecca Beausang
Regulatory Affairs Specialist and Medical Device Compliance & Quality Assurance Expert
Rebecca Beausang
MSc MDRA, ISO Auditor
Rebecca Beausang is a regulatory affairs specialist with wide expertise in the medical device sector. With an MSc in Medical Device Regulatory Affairs from SETU in Ireland and certifications as an ISO 13485:2016 Lead Auditor and MDSAP Internal Quality Auditor, Rebecca ensures regulatory compliance and Quality Management Systems (QMS) across major markets, including the US, EU, and Asia. Her role as Lead Auditor and active memberships in TOPRA and RAPS highlight her in-depth knowledge in regulatory affairs and quality assurance.
Rebecca’s professional accomplishments include post-market regulatory enforcement for MDR submissions, production site QA compliance, and engineering change analysis. Rebecca's ability to translate complex regulatory information into accessible content makes her an indispensable member of any team. Connect with her on Linkedin for insights into regulatory affairs and QMS in the medical device industry.
Rebecca’s professional accomplishments include post-market regulatory enforcement for MDR submissions, production site QA compliance, and engineering change analysis. Rebecca's ability to translate complex regulatory information into accessible content makes her an indispensable member of any team. Connect with her on Linkedin for insights into regulatory affairs and QMS in the medical device industry.
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.
Enteral Feeding Bag Set
Product Category:Feeding Sets
Indicated Use:Hospital Supplies
An Enteral Feeding Bag Set is a medical device used to deliver liquid nutrition directly into a patient's stomach or small intestine. This feeding bag kit is produced by AdvaCare Pharma in ISO and CE approved facilities in China, India, and the USA.
EVA Infusion Bag
Product Category:Feeding Sets
Indicated Use:Hospital Supplies
EVA Infusion Bag is a type of flexible plastic bag used to store and administer fluids or medications intravenously. This non-PVC infusion bag is manufactured by AdvaCare Pharma in ISO and CE approved facilities.
Medical Guide Wire
Product Category:Intravenous (IV)
Medical Guide Wire is a thin, flexible wire used to guide the placement of medical devices such as catheters or stents during surgical or diagnostic procedures. This vascular access device is manufactured in CE and ISO certified facilities by AdvaCare Pharma.
Heparin Cap
Product Category:Intravenous (IV)
Heparin Cap is a medical device used to prevent blood clots from forming in intravenous catheters by keeping the catheter open and flowing. This injection stopper is manufactured by AdvaCare Pharma in ISO and CE certified facilities.
Accessing health and wellness information is a ubiquitous endeavor, with challenges arising in discerning trustworthy, clinically relevant, and actionable content. AdvaCare Pharma USA is dedicated to revolutionizing this scenario within the healthcare sector, providing comprehensive and accessible health information to facilitate well-informed decisions for both professionals and their patients.
Learn more about our Board of Medical Advisors