Russia Medical Device Market Access and ISO 13485 certification for the ROW
Join GMEDand Alexey Stepanov, Regulatory and Quality Assurance Manager Russia and CIS at Sorin Group to have a clear view on the Russian medical device registration process, as well as how to leverage your current product submissions to make your Russian application less labor-intensive. Medical device manufacturers will learn about:
• The Russian medical device registration regulations,
• ISO 13485’s role in the Russian medical device registration regulations, and
• How a manufacturer with CE marking can re-use parts of their CE marking submission for their Russian medical device registration.
• If you’re a device manufacturer in Russia, the steps for CE marking.
Sampling of Medical Devices during Unannounced Audits
Systematic unannounced audit are now broadly implemented following the European Directives requirements and Recommendation 2013/473/EU. One of the provisions of the Recommendation relates to the sampling Notified Bodies could perform during their unannounced audits. As a leading notified body, GMEDwill cover the following topics during this webinar:
• The regulatory context surrounding the need for sampling during Unannounced Audit
• Company type and or devices for which sampling may apply,
• A Notified Body's perspective of the requirements' implementation.
CE Marking and the Roles of Notified Bodies
What does "CE" stand for? Notified bodies have many responsibilities that extend beyond simply performing product assessments for CE Marking.
As a leading notified body, GMEDwill answer the following questions:
• What is CE Marking and how does it apply ?
• The role of Notified Bodies and their responsibilities with respect to Manufacturers and the Competent Authorities.
• What is the connection between a Notified Body like LNE/G-MED, medical device manufacturers, European Competent Authorities, and the European market and what is the roles of each when it comes to get a safely performing device to Europe.
INMETRO, its Role in the Brazilian Medical Device Registration Process
INMETRO certification is a requirement for electromedical device manufacturers who wish to market their devices in Brazil, and is an additional and required step in their regulatory submission to ANVISA. But how does a manufacturer receive INMETRO certification?
Join GMEDNorth America in its Free webinar, INMETRO and its Role in the Brazilian Medical Device Registration Process to find out. This webinar will cover:
• What is INMETRO and its role in the Brazilian government
• Where INMETRO fits into the Brazilian medical device registration process
• The process to receive, and maintain, INMETRO certification.
Mexico Medical Device Market Access & ISO 13485 certification
Medical device manufacturers both in Mexico and around the world can leverage some of their expertise with their quality systems and products to open markets around the world. The webinar explore the following points:
• How Mexican manufacturers can leverage their ISO 13485 / COFEPRIS MGMP certificates to access other markets.
• If you have ISO 13485 and want to go to Mexico, what do you do?
• Mexico medical device regulation and registration process for manufacturers in North America and the rest of the world,
• How that process interacts with ISO 13485 and the Mexican GMP,
• If you're a device manufacturer in Mexico, the steps for CE marking.
Stand-alone software classification & regulation in Europe
Software (embedded, standalone, Apps) has become more important in the medical field. Medical software is nowadays essential because of its multiple purposes in diagnostic, therapy, monitoring and others, and must meet the Medical Device Directives essential requirements before being placed on the market. Understanding how your software is classified is essential for the success of your device in Europe and to ensure the software complies with the Directive. Classification allows you to determine what would be the control level of the Notified Body.
For the answers to the following questions, and more, you can tune to GMEDNorth America’s webinar on Stand-alone software classification & regulation in Europe:
• Is my software a medical device in Europe?
• How to classify my software as a medical device?
• What are the risk classes of my device according to EN 62304?
• It is possible to combine a medical device with non-medical software?
• How to classify and manage non-medical software when it is combined with a medical device?
• Which conformity assessment route for the CE marking of my software?
• What is the applicable regulation for Software as a Service?
Making the CE Mark Multitask: How to Enhance the Achievements of the CE Marking to Open More Markets
To market a medical device in Europe, the device must be CE-marked to show that it conforms to the European medical device regulatory requirements. However, a medical device manufacturer can re-use the items it uses to meet the European requirements to come close to or meet other international medical device regulatory requirements as well. For example, a manufacturer may not need to build completely different quality systems to meet the European, Canadian, and U.S. regulatory requirements. Likewise, some countries allow the manufacturer’s CE certificates to be an input in a shortened medical device regulatory application.