Software Development Lifecycle Training

ANSWERED ON THIS PAGE:

• How are IEC 62304 and IEC 82304 crucial for medical device software development?
• What does our team need to know about IEC 62304 and IEC 82304 to participate in Emergo by UL SDLC training?
• Is there a cost-effective way to learn about SDLC activities in support of medical device software development?

IEC 62304 and IEC 82304

The SDLC is a structured process to help medical device software developers meets safety and quality standards. IEC 62304 and IEC 82304 are essential standards, providing the framework for SDLC in the medical device industry. The standards lay out requirements for the development and lifecycle management of software, including risk management, maintenance and market surveillance. Adherence to these standards is critical for demonstrating compliance, enhancing product safety and facilitating global market access, making them imperative for manufacturers to successfully navigate the international regulatory landscape.

Who is the training intended for?

Emergo’s SDLC training is centered around the regulatory frameworks of IEC 62304 and IEC 82304. The training is designed to introduce participants to the crucial aspects of software development in a regulatory compliance context and is tailored for regulatory affairs (RA) staff and any personnel involved in or impacted by the software development process within medical device manufacturing organizations. Global teams can attend as the training can be provided remotely.

The full-day training provides participants with a fundamental understanding of how these regulatory frameworks impact medical device software development. 

Effective on-site or remote training

Our SDLC awareness training is an excellent value for companies training three or more employees at a time. The training is conducted at your facility or remotely by senior consultants. Our trainers are fully tuned in to the needs of the industry and understand practical aspects of meeting IEC 62304 and IEC 82304. A private training allows your employees to ask questions related to their specific situations — something they cannot do comfortably in public classes that may include competitors. Plus, in-house training can provide consistent information to every employee for a fixed price, regardless of how many employees attend.

Emergo provides regulatory compliance support for your SDLC activities

Emergo is equipped to help you achieve regulatory compliance and start selling your medical device in global markets. Training topics include:

• Introduction to IEC 62304 and IEC 82304 – Understanding their significance and system-based approach.
• Involvement and roles – Identifying key stakeholders within the company.
• Critical SDLC areas: Design and development, risk management, quality assurance and post-market surveillance
• Key SDLC processes – Verification, validation, monitoring, traceability and control of documentation.
• Additional regulatory considerations – If needed, inclusion of specific regional regulations relevant to participants' products.

The training is tailored to meet the specific needs of your organization, considering the type of medical device, the current level of staff expertise, delivery mode (on-site or remote) and the number of participants. This supports a relevant and impactful learning experience.

Collaborating with Emergo for your SDLC awareness training provides opportunities for your team to be educated by experts in medical device regulatory compliance. Participants will leave the training with a solid foundation in SDLC activities and the regulatory landscape, ready to effectively support your organization's compliance efforts.

Common questions regarding regulatory SDLC requirements

What foundational knowledge of SDLC do professionals new to medical device software development need?
Professionals new to medical device software development need to understand the stages of SDLC and how it integrates with regulatory standards like IEC 62304 and IEC 82304 to enhance safety, reliability and compliance of medical software. This foundational knowledge is essential not just for designing and developing compliant software but also for understanding the broader regulatory landscape, helping align all aspects of software safety, quality, and maintenance with international expectations.

Why is awareness of IEC 62304 and IEC 82304 important for achieving global market access?
Awareness of IEC 62304 and IEC 82304 is crucial for global market access because it demonstrates a commitment to international safety and quality standards, aligning products with regulatory expectations and simplifying the approval process across different jurisdictions.

What initial steps should a medical device manufacturer take to comply with these standards?
Manufacturers should start by familiarizing themselves with the key principles of both standards, conducting a gap analysis to identify areas where their current processes need adjustment and implementing a structured software development lifecycle that incorporates risk management and quality assurance practices from the outset.