Training course designed and delivered by our expert dedicated to the Transition to the new ISO 13485:2016 Standard
Soka University of America
Small Conference Center
One University Drive
Aliso Viejo, CA 92656
The Regulatory Convergence is RAPS’s annual multi-day gathering of the global regulatory community. RAPS is the perfect opportunity for our clients to meet and discuss with some of our experts and specialists.
Medical devices manufacturers are regularly asked about the safety of their products when introduced into an MRI scanner (Magnetic Resonance Imaging).
These questions usually come from competent authorities, notified bodies or medical teams. This is the subject of a regulatory strengthening and forms part of a growing number of standards (ISO 14630, ISO 14708, EN 45502, etc.).
The placing on the market of an implantable device is now impossible in some countries without prior information on the product safety during an MRI exam.
Therefore it becomes a major issue for MD manufacturers, especially with regard to implantable Medical Devices.
In June 2016, the new version (Rev.4) of MEDDEV 2.7.1 European guidance on the clinical evaluation of medical devices (MD) was published. It does not revolutionize the clinical evaluation approach but significantly increases the demands on the content of the file.
The new guidance is longer and more detailed, in order to provide numerous supporting examples and to clarify some terms. It does not introduce new requirements per say.
This newsletter presents the changes introduced by the guidance revision, applicable since June as there is no transitional period planned in the text.
Orange County Regulatory Affairs Discussion Group (OCRA) is inviting QA/RA management as well as key decision makers (CEO, CFO, and Internal Counsel) to discuss the business and financial implications of meeting the new regulations and engage with both seasoned Industry and Notified Body professionals to obtain valuable insights and information on how to proactively prepare for the transition to the new EU regulations for medical devices and IVDs.5.
This year, Jawad Mahdavi, Lead Auditor at LNE/G-MED North America will discuss the new MD regulation and its Implications for Medical Device manufacturers.
To download the program and register, click here.
In September 26th 2012, the European Commission proposed a draft for an in vitro diagnostic Regulation in order to overcome flaws and divergences in interpretation of the current IVD Directive 98/79/EC and to further strengthen patient safety.
Since then this draft have been amended by the European Parliament in October 2013 and the European Council provided its approved revision on September 21st 2015.
Since its first publication in 1987, ISO 9001 has been revised several times to remain relevant and in line with the market needs of businesses. A new revision of the standard was launched in September 2015; replacing the latest version published in 2008. With over 1.2 million companies certified around the world, ISO 9001:2015 introduced several changes; some of those are significant as they impact key areas of the companies’ Quality Management System.