How to Implement the ISO 13485 in Your Company?
Duration : 90 Minutes
Dr. Frank Stein,
Prof. Dr. Dr. h.c. Frank Stein, medical engineer, medical engineering experience since 25 years, clinical and research experience in cardiac surgery and cardiology, industrial experience in ophthalmology, neurology, traumatology and dental implants, active implants, active devices, international p Read more
The ISO 13485:2016 is the essential standard for quality management systems for medical device manufacturer, importer, distributors and dealers in Europe and in other international markets e.g. Canada, Australia, Japan, Taiwan. This standard has received some changes e.g. responsibility of outsourced processes, computer system validation, control of nonconforming products etc. The understanding of this changes and how to implement changes is essential to keep the certificates valid and to improve the quality management system. The ISO 13485:2016 is the basic for MDSAP – certificates and for the EU MDR certificates.
Course Objectives:
• Introduction, who should apply the ISO 13485:2016
• Overview about the changes of the ISO 13485:2016
• Explaining of each change
• Smart and fast ways to implement the changes in your quality management system
• Fast track internal audit to approve the changes
Why Should You Attend:
The medical device manufacturer importer, distributors and dealers in Europe and other international markets like e.g. Canada, Australia, Japan, Taiwan need to understand the requirements of the ISO 13485:2016, because this standard is the essential standard for quality management systems. This standard has received some changes e.g. responsibility of outsourced processes, computer system validation, control of nonconforming products etc. The understanding of this changes and how to implement changes is essential to keep the certificates valid and to improve the quality management system. The ISO 13485:2016 is the basic for MDSAP – certificates and for the EU MDR certificates.
Course Outline:
• Closer regulatory binding of the ISO to the new EU MDR
• Adjustments in the management review
• Responsibilities for outsourced processes
• Labeling, UDI
• Changes in the control of nonconforming products
• How to deal with ISO 9001 or any other quality management system in multidisciplinary quality management systems
What You Get:
• Training Materials
• Live Q&A Session with our Expert
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points
Who Will Benefit:
• Executive management
• Regulatory management
• Regulatory affairs and quality assurance professionals
• Consultants
• Sales/marketing management
• Senior and mid-level management
• Quality system auditors
• CEO’s,
• Quality Personnels
• Regulatory Affairs Manager and Quality representatives of
• Medical Device Manufacturer
• Importer,
• Distributors and
• Dealers who work in the countries, which require ISO 13485
Please reach us at 1-888-844-8963 for any further assistance or if you wish to register
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