This recorded webinar course will provide guidance on how to perform the transition to the Medical Device Quality Management System (QMS) Standard ISO 13485:2016.
In Particular will discuss the following points:
1. Comparison with previous version of ISO 13485
2. Impact on existing QMS
3. Consistency with new ISO 9001:2015
4. Regulatory impact
The new ISO 13485:2016 standard provides an effective framework to meet the comprehensive requirements for a medical devices quality management system; for manufacturers and service providers to both comply and demonstrate their compliance to regulatory requirements.
ISO 13485:2016 supports the design of a quality management system that establishes and maintains the effectiveness of a manufacturer’s processes to ensure the consistent design, development, production, installation, and delivery of medical devices, or related services, that are safe for their intended purpose.
The new edition is applicable across the whole supply chain and seeks to address the entire lifecycle of a medical device.
Why You Should Attend:
Transition time has started! ISO 13485:2003/2012 and ISO 13485:2016 are now coexisting, start implementing the changes to your Quality Management System will make you ready for the switch. Some of the biggest changes between the 2003/2012 and 2016 version include:
Application of risk-based approaches in the 2016 standard now extend beyond product realization processes alone.;
Increased linkage with regulatory requirements, particularly for regulatory documentation;
Application to organizations throughout the lifecycle and supply chain for medical devices;
Harmonization of the requirements for software validation for different software applications. In previous versions of ISO 13485, this has not been as clear as it needed to be. Software validation and on-going functional verification of software are now equally importance across the standard.
Emphasis on appropriate infrastructure, particularly for production of sterile medical devices, and addition of requirements for validation of sterile barrier properties.
Additional requirements in design and development on consideration of usability.
Emphasis on complaint handling and reporting to regulatory authorities
Planning and documenting corrective action and preventive action
Who Will Benefit:
Regulatory Affairs specialist
Medical Affairs specialist
Clinical Affair specialist
Students must view the entire program and successfully pass an online, multiple choice final assessment with >80% passing grade.Certificate will be printable in PDF format immediately after satisfying requirements.
Online Training Programs Includes:
Answer to questions submitted during the webinar.
An online final assessment with multiple choice questions.
A Certificate of Completion.
5 Months Access to the recorded session
Live Course Presented and Commented by:
Alice Ravizza is a Biomedical Engineer, graduated at Politecnico di Milano. She has great and extensive experience in R&D and QA / RA in the biomedical field. She is specialized in supporting Medical Device companies in building up and improve Quality System Management and assure Compliance through all the internal processs. She assist companies during the registration process for CE Mark making sure all the technical documentation is compliant to applicable standards and regulations. She is aswell an experienced Trainer and Lecturer.