Medical Devices - 321 Gang Inc.

Avoid rework and project delays with market-leading requirements management solutions

Implement compliant, traceable solutions that manage a wide range of requirements to achieve faster deployment.

Learn more about our Medical Device solutions

Agile Medical Device Development

Join the Continuous Engineering Experts’ Bryan Smith as he welcomes Dr. Harry Koehnemann – SAFe Fellow and SPCT – from Scaled Agile, Inc. to the show, as they discuss how medical device companies can leverage new techniques in agile development to reduce costs, increase productivity and accelerate innovation throughout their organizations.

Compliance, Regulations and Traceability: How Lean, Agile and SAFe principles fit

Join the Continuous Engineering Experts’ Bryan Smith as he welcomes the Co-Founder and Chief Methodologist of the Scaled Agile Framework (SAFe), Dean Leffingwell to the show as they discuss how you can apply Lean-Agile and SAFe methods to build these systems faster and better, while also addressing critical compliance requirements.

321 Gang and IBM Engineering Medical Device Development

IBM Engineering: Medical Device Development Solutions

In this free online learning module we’ll discuss how lean-agile and scaling principles support medical device development and how to build them using IBM’s Continuous Engineering solution.

Topics include:

Manage Change & Configuration Management
Testing Quality Assurance & Traceability
Agile MBSE for Med Device Dev
Automating Requirements

Client Success Stories

Bayer Radiology

In this presentation, we will review how Bayer Radiology transformed paper based verification and validation process into electronic process. How it reduced manual intervention in the compliance process. In addition we will mention how we adopted RQM in one quarter, and specific RQM functionality that has proven to be critical to our adoption.

Watch here

Resources

Learn How

In this session, we’ll spend our time seeing how requirements can be managed while reviewing and using the requirements in the context of their downstream users.

An Introduction to AAMI TIR45

This guidance, now a FDA Recognized Consensus Standard, provides recommendations for aligning the concepts of Agile Software Development with regulatory requirements and expectations. In this video, we will describe the fundamental concepts of TIR45 and explain the recommendations that medical device manufacturers should address in their use of Agile methods.

WebinarBanner_MedDevices_SAFE_ATaleofTwoSystems_v2-compressor

Watch Now

Like a comparison taste-test of two sodas, what if you could watch side-by-side two medical device systems being built, one with a traditional waterfall process and one with Scaled Agile? In this webinar, we highlight the experiences, learnings, economic and regulatory outcomes of each of these development efforts.