The course offers explanation and illustrative high-quality presentations on difficult concepts of medical devices’ design control as per ISO 13485:2016 and best industrial practices. ISO 13485:2016 is the current international standard for the QMS (quality management system) of medical devices' manufacturers and suppliers. The standard title is also extended with a supplementary expression: "For Regulatory Purposes". It reflects the standard is also designed in a way to help companies in meeting the homogenous regulatory requirements as well.
Design and development in a QMS (quality management system) is the most difficult part for any industry. In the same way; medical devices sector are no exception and due to increased regulatory concern in this industry; design and development in medical device is even more complex process which encompasses different phases and roles. Hence this course simplifies the process of design control for medical devices.
The course presents an exclusive model based on ISO 13485:2016 requirements on design control compared with popular FDA waterfall model. The model is known as the Rising model and is designed by the Speaker and Presenter of this Webinar Course and is unique way of explaining the ISO 13485 requirements on design and development.
Agenda
1. ISO 13485:2016 Standard Introduction
2. Discussion on FDA Waterfall Model and Rising Model
3. Coverage of followings requirements of design and development:
- Planning
- Procedure
- Inputs
- Outputs
- Review
- Verification
- Validation
- Transfer
- Changes
- File
4. Summary of ISO 13485 Requirements on Medical Devices’ Design
Samples
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Companies Mentioned
- DePuy
- J & J
- Carefusion
- Teleflex
- KLS Martin
Speakers
Mr Syed Muhammad Waqas Imam,
Chief Consultant ,
Exoexcellence (SMC) Pvt. Ltd.S.M. Waqas Imam is chief consultant of Exoexcellence (SMC) Pvt. Ltd, a consulting company; with over 10 years’ experience in the implementation of various ISO standards and compliance of U.S. FDA and EU regulations. He is now serving as a full-time consultant. He has worked with various manufacturing companies in different positions from Quality Assurance and Regulatory Affairs Manager to Integrated Management System Expert and has helped companies like giants in steel manufacturers, medical devices manufacturing industry, brush manufacturing company, lead acid battery manufacturing industry and bulk handling terminals etc.
He is a qualified industrial engineer. He specializes in quality assurance, quality management, lean and continuous improvement, regulatory affairs, Integrated Management System problem remediation etc. He is also certified by IRCA CQI recognized Lead Auditing course on ISO9001, ISO14001 and other management system standards, moreover also a certified IOSH Managing Safely professional. He had supported his employers and clients in implementing the requirements of ISO 9001, ISO 14001, ISO 45001, ISO 13485 and ISO 50001 in different manufacturing industries.
As a medical devices’ compliance expert; he has served as Expert Blog Writer for 13485Academy and wrote expert articles on various topics of ISO 13485:2016. He has also partnered with TS Q & E, medical devices consultancy for Europe and has authored several articles on European Compliance. He is also associated with Medical Device Community as Ambassador. He also writes compliance articles on medical devices for Surgical Units. He also specializes in ISO 14971 product risk management files and reports, FDA/EU design control, design history files, and technical files. He has published several numerous articles, conducted workshops and webinars worldwide on CGMP subjects.
Who Should Attend
This webinar will provide valuable assistance to all companies working with design and development of medical devices and are looking for conformance of ISO 13485:2016 certification or compliance with FDA Design Control Requirements.
The employees who will benefit include:
- Executive management
- Research and Development management
- Regulatory management
- Regulatory affairs and Quality Assurance professionals
- Consultants and
- Senior and mid-level management
- Quality system auditors
