ANSI/AAMI/IEC 62304 is a Recognized Consensus Standard by the US FDA and a harmonized standard in the EU. This means that compliance to it provides a presumption of conformity to the requirements within those jurisdictions. Not complying with the standard has shown to lead to longer regulatory review times and frequent rejections.
Software continues to get increasing amounts of attention by regulators and reviewers. Compliance with 62304 helps pave that pathway but a practical application of the standard is not always intuitive. The standard gives the impression, to many, that it enforces a particular methodology, but the standard can be adopted irrespective of the development methodology. This training session will discuss techniques and methods that have proven successful in regulatory (and test lab) submissions. Not complying with the standard has been shown to lead to longer regulatory review times and frequent rejections.
IEC 62304 is both a recognized consensus standard by FDA and a harmonized standard in the EU; therefore, being compliant with the standard is the most expedient path forward for medical device products that are or contain software. IEC 62304 is also called out as a standard under the IEC 60601-1 umbrella and thus compliance to 62304 is also the best path through product safety testing (if applicable to your system). This webinar will identify the deliverables expected by the standard and provide some guidance on the content expected.
You will learn about the rationale behind the requirements and how those are applied to the deliverables. Many software developers see the standard as imposing a “waterfall” development methodology; however, this is not the intent and we’ll discuss how other methods can be applied. Further, there are a few “twists” that tend to confuse software developers that haven’t worked on medical device projects.
Areas Covered in the Webinar:This webinar is intended for software developers, software development managers, quality personnel associated with software development projects, and project managers who manage projects with a software development component from industries including medical device and IVD.
Don HurdVP Quality and Validation Services , The Realtime Group
Don Hurd has over 35 years of experience in supporting development of applications of or containing software in regulated industries, the last 17 in medical devices. With his diverse background, Mr. Hurd provides a unique insight into driving product quality and ensuring high productivity of development organizations. Mr. Hurd is currently the Vice President of Quality and Validation Services for The Realtime Group, a contract R&D firm specialized in serving the regulated industries, primarily medical devices. In this role, Mr. Hurd led the company to certification in both ISO 9001 and ISO 13485, maintaining certification for nearly 15 years. In his role at Realtime, Mr. Hurd supports clients in efforts ranging from Quality Management System development, deployment, and remediation; product and development quality planning; verification and validation of products, product software, and non-product software; supplier qualification, approval, and management; transitioning product from development to manufacturing; supporting post-market vigilance / surveillance; and interfacing with ISO auditors and FDA inspectors. Mr. Hurd has been an ASQ Certified Quality Auditor since 2009. Mr. Hurd is active in the ASQ Biomedical Division Discussion Group, ASQ Audit Special Interest Group, and bionorthTX, holding leadership positions in each.
Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. FDATrainingAlert would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.
Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.
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