Find and Fix Software Defects Before They Derail Your Timeline

For companies in the medical device industry, reviews of source code and requirements are essential. They enable teams to reduce risk and identify defects as early in the development process as possible, which is especially important for complying with the FDA's 21 CFR part 11 and ISO 13485 standards.

Collaborator empowers teams to conduct peer code and document reviews early and often, to ensure premier quality throughout the entire application lifecycle. Cross-functional teams can remotely and collaboratively improve on deliverables all in one place. Whether you are a product manager writing and reviewing requirements or a software architect building the latest feature, Collaborator helps you and your team stay on the same page.

Read: Developing Medical Device Software with Recall Prevention in Mind

 

Preventing Recalls in the Medical Device Industry by Focusing on Peer Reviews

With recalls on the rise across the industry, how can medical device companies prepare moving forward? Join us for a discussion of how some of today's leading medical device are utilizing peer reviews to meet industry standards, while designing the next generation of digital health solutions.

In this webinar, we discuss:

  • Recent changes in the industry and impacts on process
  • The best practices for managing quality throughout the development lifecycle
  • How medical device companies can prepare for process audits and evaluations
 

Create Custom Templates and Checklists to Meet Title 21 CFR Part 11

In Collaborator, you can build custom review templates to ensure that each type of peer review meets your specific compliance needs. Formalize reviews by setting rules for each template that work in the background and establish required criteria that must be met prior to submission.

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Improve Your Process Across the Development Lifecycle

Make sure that your specifications and product requirements are lining up every step of the way. Conduct comprehensive code and document reviews faster and easier with built-in capabilities like e-signatures and review notifications.

Design

Make comments and see changes to user stories, requirements, and design documents.

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Development

Leverage custom review templates and workflows to take your code reviews to the next level.

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Testing

Bring in other departments to ensure that test cases and plans align with requirements. 

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Deployment

Create deployment scripts and conduct code reviews on the infrastructure level.

Schedule a Demo
 

Make Compliance and Audits Easier by Archiving Code and Document Reviews

During an audit, you could get a question about why a specific change in code was made. Do you have enough documentation to follow the digital thread? Collaborator offers a content archiving capability that allows you maintain data continuity and manage server space. Our save to zip feature also enables you to make a hand off to compliance so that you can quickly go back to building that new feature.

Learn About E-Signatures in Collaborator

 

It’s very powerful to have Collaborator create a documentation package that documents reviews with a great level of detail structured in a way to facilitate audits and integrate with other project documents. We also benefit from a 70% reduction in our code review and test review timeline.

Aaron Peterson
Vice President of Research & Development

Build Custom Reports to Drive Process Improvement and Quality Management

How do you show your review process in a tangible way? With Collaborator, custom reporting is a standard, out-of-the-box capability. Whether you're trying to illustrate your review efforts for a compliance audit or just looking to find the gaps in your process, Collaborator's reporting feature can be leveraged to drive insights and document your team's compliance with code and document review standards. 

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Questions? Email us at sales@smartbear.com or call: U.S. +1 617-684-2600, EMEA +353 91-398300, APAC +61 391929960
 

Start Your Collaborator Trial Now

Get more out of your code review process. See why teams are able to find and fix more defects earlier with Collaborator.

  • 30 Days Free
  • Customize reviews for any workflow
  • Industry-leading native integrations

 
 

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