This webinar will help you understand specific product verification and validation requirements for medical devices to comply with ISO 13485: 2016 and FDA quality system regulations. It will focus on the topics such as product development process, traceability and risk management at all stages, design outputs and documentation in DMR and DHR, design verification and design validation activity cycles and more.
Why Should You Attend:
Design Control is an integral part of any quality system in regulated industries. FDA Quality System regulation, Quality System Inspection Techniques (QSR and QSIT) and ISO 13485: 2016 have specific product verification and validation requirements that must be fulfilled in the medical device industry. FDA is getting more and more stringent about product design requirements for risk management and to fulfil its mandate for safety and efficacy of all medical devices. The design controls are now being expected from outside equipment manufacturers (OEM) and suppliers to the medical device industry.
The goal of this webinar is to educate you on the key areas that you need to focus on to fulfil the design control requirements for your medical device.
Areas Covered in the Webinar:
- Product development process overview for design control management in the medical device industry for introducing a new product and sustaining your product design throughout the product life cycle.
- Overview of applicable design verification and validation requirements for your globally distributed medical devices.
- Testing requirements including the pertinent ISO guidelines to fulfill the key acceptance and evaluation criteria for your products at the different stages of its evolution and its life history.
- Translation of user requirements into design inputs and role of testing and regulatory requirements.
- Fulfilling critical to customer and critical to quality requirements.
- Design verification and design validation activity cycles.
- Traceability and risk management at all stages.
- Design outputs and documentation in DMR (Device Master Records) and DHR (Device History Records).
- Proof for how design outputs meet functional and operational requirements of your device.
- Compatibility of the design with components and other accessories including software, packaging and labelling management.
- Criteria for establishing test requirements to fulfil acceptance criteria for final products after validation and into the manufacturing cycle.
- Design reviews at major decision points to withstand regulatory scrutiny.
- How are changes and their effects controlled and documented during the device life cycle?
- Key concepts for translating your device customer requirements into design inputs, outputs and fulfill product compliance/ audit requirements throughout your product life cycle.
Quality and Regulatory Manager ,
Ms. Chettiar received her M.S. in Regulatory Affairs for Medical Devices in Minnesota, USA, M.A. SC in Chemical engineering from University of British Columbia in Canada and her B.S. and M.S in Applied Chemistry from the University of Madras, India. Ms. Chettiar is now enrolled in MS Applied Clinical Research Program focusing on medical devices.
Meena is currently working as a Quality and Regulatory Manager at ProMed Pharma, Medical and combination device manufacturer. Meena has worked as a Senior Supplier Quality Engineer for Covidien with drug coated balloons and guide wires, for Baxter Bio Surgery, as a Senior Quality Manager at Teva Pharmaceuticals for over 10 years and as QC lab supervisor at Land O' Lakes. Meena has also worked for Agriculture and Health Canada in several technical capacities for about 10 years.
Meena has played a key role in quality system implementations in the food, pharmaceutical, and medical device industries. Meena has participated as the lead supplier/internal/GMP auditor in several compliance audits in the US and abroad. Meena is the Vice chair of member development for MNASQ (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 served as an instructor for these ASQ certification classes since 2006. She is a certified instructor for ASQ learning institute for CBA and an adjunct instructor for Medical Technology Quality graduate program for St. Cloud State University in Minnesota. Meena is a coauthor of the CBA (Certified Biomedical Auditor) Primer for the Quality Council of Indiana.