Agile Quality Systems

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Agile Software Development Coaching

Agile Software Development is well established as an effective way to produce software quickly and effectively, but medical device software developers have concerns about the suitability of Agile. As a pioneer in the application of Agile to medical device software, I can address those concerns to help organizations find the advantages of Agile while maintaining high-quality software and compliant development processes.

As one of the lead authors for "AAMI TIR45 Guidance on the use of AGILE practices in the development of medical device software" and lead instructor for the associated AAMI Course (link to AAMI site), I provide industry-specific guidance on the safe and effective use of Agile.

Agile-related services include:

- General eduction (Classroom or small-group) on Agile principles and practices to provide foundational understanding

- Organizational-specific consulting to tailor Agile practices and make quick decisions on context-specfic solutions

- Embedded coaching to quickly move teams through the learning curve

Training on Medical Device Regulations and Standards

For organizations new to the medical device world, or those who need a refresher, Agile Quality Systems provides foundational training and advanced coaching on the FDA Quality System Regulation and related standards.

Training courses include:

Introduction to Medical Device Quality Systems

- Design Controls:

   = FDA Design Controls and ISO 134585 Product Realization Requirements

   = Revitalizing Design Controls

- Introduction to Risk Management based on ISO 14971

Implementation of IEC 62304

- Agile Development for Medical Device Software

- Agile Development for Medical Device Systems

- Validation of non-product Software, based on AAMI TIR36

Customized training on the above and other topics can be provided, developed after an initial assessment of your organization's current state and desired improvement areas.

Quality System Improvements

For medical device development organizations motivated to improve their quality management system, Agile Quality Systems can help. Whether the motivation comes from issues identified by regulators, or an internally identified need to improve, I work with the development team to identify opportunities and provide specific solutions to be implemented within the organization’s time, budget, and capacity constraints. 

For new medical device developers needing to establish a quality management system, I provide a comprehensive and simple set of procedures and templates for software, hardware, and systems development, focusing on compliance to ISO 13485, FDA 21CFR820.30, and IEC 62304. 

As an experienced creator and user of product development processes, I focus on practical procedures that fit with the organization's context and the product's risk level.

Learn More

Decades of medical device experience is too much to summarize here. Contact me for more information on how Agile Quality Systems can help your organization.