Developing IEC 62304 Compliant Software: Proven Tips & Best Practices скачать в хорошем качестве

Developing IEC 62304 Compliant Software: Proven Tips & Best Practices

This on-demand webinar, hosted by Greenlight Guru, focuses on guiding MedTech professionals in developing software compliant with the IEC 62304 standard. Cathy Wilburn, Director at The RND Group, a Gener8 Company, shares her expertise in medical device software lifecycle management, emphasizing the importance of aligning with FDA and EU regulatory requirements and providing a roadmap for successful implementation. Main points covered: 1. Aligning with FDA and EU regulatory requirements for IEC 62304 compliance. 2. Conducting gap analysis and developing plans for addressing non-compliance in software development processes. 3. Utilizing iterative software development lifecycle models. 4. Importance of comprehensive process and product documentation. 5. Training and awareness promotion of IEC 62304 among all personnel involved in software development. Target Audience: • Regulatory Affairs Professionals & Management • Quality Professionals and Management • Medical Device Executives • Product Development Engineers and Management Access the printable slides for this presentation by visiting: https://www.greenlight.guru/webinar/d...