In vitro diagnostic (IVD) medical device Software, whether standalone or on a device, will now face a higher level of Regulatory Compliance based on the new IVD Regulations (IVDR) coming in May 2022. Any IVD Companies interested in commercializing their IVD Software will also now require FDA 510K Clearance to be able to sell their products. Learn what is required to successfully support the IVDR standard/510k regulatory requirements by ensuring IEC62304 Compliance with software.
This course will ensure that IVD Diagnostic companies that depend on custom software to deliver their service will know exactly what documentation needs to be prepared to ensure compliance and prevent costly revenue interruptions due to failed unannounced audits as required by the new IVDR 2022 regulations. They will also know how to ensure the documentation is prepared correctly specifically for the software portion of the submittal so that it will comply preventing delays of the 510(k) approval.
Companies can also face potential audit risks and serious findings post submittal that can block their ability to ultimately sell their product successfully. This course will ensure that you know what is expected to have in place for compliance for your company during the preparation of a 510(k) to prevent this risk.
Key Learning Objectives
- Know how to ensure the software documentation is prepared correctly specifically for the software portion of the submittal so that it will be in compliance with the latest 2022 IVDR regulations.
- Avoid potential audit risks and serious findings which can prevent a company’s ability to sell their service.
- Know what is expected to have in place for compliance for your company if you wish to prepare a 510(k) filing if you plan to sell your software.
- Ensure a faster 510(k) approval because the documentation is complete and comprehensive.
- Prevent costly time to market issues because 510(k) has been rejected completely because of software.
Who will Benefit
- IVD Medical Device Software Regulatory professionals,
- IVD Medical Device Software Quality Assurance Engineers,
- IVD Medical Device Software Quality Senior Management,
- IVD Medical Device Software Company Senior Management
- IVD Medical Device Quality Engineers
- IVD Medical Device Quality Senior Management
Industries who can attend
This 60-minute online course is intended for professionals in the Medical Device, Biotechnology,Pharmaceutical Industry. Although not presently stated in the draft , the same guide could be used by FDA Regulated Industries personnel
Faculty Nancy Knettell
Nancy Knettell, Founder and Principal at Software510, LLC, has over 30 years in combined Mechanical Design, Software Development, and Regulatory experience primarily in the Medical Device industry for such major medical device companies such as Smith and Nephew, Philips Medical, CR Bard, Kollsman Medical, Deka Research, Becton Dickenson, and Johnson and Johnson.