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.Read More
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.Read More
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.
- Manage Change & Configuration Management
- Testing Quality Assurance & Traceability
- Agile MBSE for Med Device Dev
- Automating Requirements
Client Success Stories
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.
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.Read More
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.Read More
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.Read More
The Future is Now
We have helped our clients:
- Increase productivity by 25-75%
- Reduce development costs by 50-60%
- Accelerate time to market by 20-40%