FDA proposed changes to ISO 13485: 2015 and Medical Devices Quality Management Systems



Differences in regulatory requirements between Medical Devices and Pharmaceutical products poses unique challenges to companies that want to manufacture devices that contain drugs and biological products (aka Combination Devices). Large and small medical device companies who want to embark into this new journey by adding a coating of a slow eluting drug product to their medical devices face challenges that range from facility design, clean room requirements and changes in testing requirements. Understanding the major considerations in their regulatory path to fulfilling the quality system requirements (QSR) in the ever changing, fast growing, complex arena of medical devices and pharmaceutical GMP considerations under one QSR umbrella is necessary for US FDA product registration through CDRH and CDER.

This webinar presents important facts to simplify the planning and execution phase in your journey towards becoming a combination device manufacturer by incorporating the essential quality system requirements in your company. The experience shared at this webinar is based on proven successful practices and hence practical tips that will be useful to employees of established and emerging combination device manufacturers will be presented to you.

Areas to be Covered:

Brief introduction to common combination devices, why combination devices to advance patient care and provide competitive market advantage?
Types of combination products and which QSR applies to which combination/primary mode of action.
Current Guidance Documents.
Why a one size fits all approach to QSR just will not work for combination devices?
Quality System Regulation, 21 CFR Part 820/ ISO 13485 Vs 21 CFR Part 210/21, 21 CFR Part 4
Guidance for Industry and FDA staff on GMP Requirements for Combination products released in January 2015
Unique challenges and an insight into how you can overcome them
Implications of FDA’s Final rule for clarification of cGMP requirements for combination products
Why and how can medical device manufacturers broaden their in house and consulting expertise
How to sufficiently anticipate and address the challenges in quality and regulatory issues that must be considered while expanding your Quality System Requirements (QSR) from Medical Devices to Combination Devices
Role of primary mode of action (PMOS) of your device and submit paper work to the respective EU and US FDA regulatory body.
Implementation of unique pharma provisions of 21 CFR 211 such as
Expiration dating
Out of specification
Stability testing
UDI Labelling Requirements
MDR for complaints
Clean room environment
Managing critical quality attributes (CQAs) and critical process parameters (CPPs), clinical studies, submission requirements for approval and clearance and post market vigilance differences.

Who will Benefit:

A must attend webinar for Managers, Supervisors, Leads, Specialists, Engineers and Groups in Department of:
Research & Development
Manufacturing and Process Engineering
Design Assurance
Quality Assurance
Quality Control
Design Engineering
Document Control
Regulatory Affairs

Meena Chettiar

Meena Chettiar currently works as a Quality and regulatory Manager at ProMed Pharma in Minneapolis. Meena has worked as a Senior Supplier quality engineer at Covidien, Senior Quality Associate (Lead Auditor and CAPA Coordinator) at Baxter Bio Surgery in St. Paul, MN. Meena worked as a Senior Quality Control Manager at Teva Pharmaceuticals for over 10 years and as Instrumentation lab supervisor at Land O’ Lakes. Meena has also worked for Agriculture and Health Canada in several technical capacities for about 10 years before immigrating to the United States.

Meena made the transition to the medical device industry after completing a MS in Regulatory Affairs for Medical Devices through St. Cloud State University in 2010. Meena has played a key role in quality system implementations in the food, pharma, and medical device industries. Meena has participated as the lead supplier/internal/GMP auditor in several Compliance audits in the US and abroad. She has a strong auditing background in the pharmaceutical and medical device auditing. Meena is a senior member of ASQ (American Society for Quality) and is ASQ certified CQA (Certified Quality Auditor), CBA (Certified Biomedical Auditor), CQIA (Certified Quality Improvement Associate), and CMQ/OE (Certified Manager of Quality/Organizational Excellence). She has been serving as an instructor for these ASQ certification classes since 2006 and has conducted quality and medical device related training classes in her current position at Baxter.

Meena is a coauthor of the CBA (Certified Biomedical Auditor) primer for the Quality Council of Indiana. She is currently an adjunct instructor for the medical technology quality program at St. Cloud State University in Minnesota. Ms. Chettiar received her M.S Regulatory Affairs and Services for Medical Devices from St. Cloud State, Minnesota, M.S. in Chemical engineering from University of British Columbia and her B.S. and M.S in Applied Chemistry from the University of Madras, India. Meena is happy to teach webinars for the Compliance Trainings and continue to contribute towards quality and regulatory compliance.


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  • Presentation Handout in .pdf format
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