ISO 13485:2016 specifies requirements for a Quality Management System that can be used by an organization in the design, development, manufacture, installation, and service of a medical device, as well as in the design and delivery of related services that also covers areas such as logistics, distribution, testing, calibration and sterilization. ISO 13485:2016 is therefore aimed at organizations interested in the entire “life cycle” of medical devices. The main objective is to foster global harmonization of requirements for MD standards.
The training course “ISO 13485 – The Quality Management System for Medical Device” will examine the norm and highlight the most important points with the help of examples.
ARE YOU INTERESTED IN MEDICAL DEVICE TRAININGS?
Sign up for 3 courses and you’ll get a 15% discount*, while if you choose 5 courses you’ll get a 20% discount*. You may choose from these trainings:
- ISO 13485 – The Quality Management System for Medical Device
- ISO 14971 – Risk Management System for Medical Device
- Medical Device Regulatory Affairs
- Medical device clinical evaluation
- Advertising medical devices and dietary supplements
- HIGHLIGHTED TRAINING – Combination Products in EU and US
(*) discounts apply to full prices and cannot be combined with other promotions. The promotion is valid for the enrollment of the same attendee in 3 or 5 courses among those proposed.
Key points of the training
- Understand the requirements of a Quality System for medical devices
- Share an overview of management systems for quality
- Understand the requirements of ISO 13485:2016 including through comparison with ISO 13485:2003 and the differences from ISO 9001:2015
- Understand how to conduct internal audits that comply with the standard by taking a risk-based approach
- Provide insights for your own Quality System
09:00 – 13:00 COURSE SESSION
- Requirements for a Quality Management System Applied to Medical Devices
- Overview of the Standards for Quality Management Systems
- Main aspects of ISO 13485:2016: documentation, resources management, monitoring and improvement
- Risk-based thinking and auditing with a process-oriented approach
- Risk management
Managers of the Quality Management System and Regulatory Affairs, Managers relating to the medical devices sector, Managers of other company areas.
The course will be carried out through live lectures. Practical examples will be showcased, providing delegates with real life examples to be applied in their daily job life.
For online trainings the access link will be sent 2-3 days before the start of the training.
5% discount for registrations within 1 month before the start of the training, 10% discount for registrations within 2 months before the start of the training. VAT not included. Please inquire for discounts for multiple registrations. Discounts are not cumulative.
In order to cancel enrolment to an event, please email firstname.lastname@example.org within 2 weeks before the starting date of the event. Once this term will be expired, the entire fee will be charged.
It is possible to replace a participant attendance without additional cost, simply by contacting email@example.com. It is asked to notify the participant replacement request within 5 days before the starting date of the course/event, specifying the full name and surname of the enrolled participant as well as the full name and surname of the substitute.
If the minimum number of participants is not reached, Pharma Education Center reserves the right to cancel or schedule the event for another date. Formal communication will be given within 5 days before the event date. In this case Pharma Education Center will refund the registration fee in full and without additional charges. Alternatively, the participant can request a spendable coupon for participating in another PEC event scheduled in the current year.
Graduated in Chemistry and Pharmaceutical Technologies in 1987 at the University of Siena, she has thirty years of experience in pharmaceutical companies, covering for a long time the role of Qualified Person and Quality Assurance Manager. She has personally faced numerous inspections by Regulatory Bodies (AIFA, Ministry of Health, Notified Body) as well as inspections by customers. The long experience has allowed her to know the regulations and processes concerning medicines: sterile, non-sterile, injectable, oral and homeopathic. She also had the opportunity to learn about the regulations on cosmetics and specialized in the field of sterile and non-sterile medical devices, including IVDs. Since 2019 she has been carrying out consultancy activities as Quality Management Manager, Auditor (GMP, GDP, ISO9001:2015 and ISO13485:2016) and Trainer within Pharma D&S and Pharma Education Center.
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