Quality Peer Reviews for Healthcare Software

Make Software Assurance a Seamless Part of Your Peer Review Workflow

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.

“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.”

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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.

This video shows how custom templates work in Collaborator.

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Capture Metrics on Reviews and Make Iterative Process Improvements

How do you assess if your peer reviews are effective? With Collaborator, custom review reports are a standard, out-of-the-box capability. Whether you’re trying to illustrate your review efforts for an audit or looking to find skill gaps across your team, Collaborator’s reporting feature can be leveraged to drive insights and document your team’s work. It is easy to customize reports to highlight metrics that matter or align with compliance burdens.

This video shows custom reports and metrics in Collaborator.

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Webinar: 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? We recently hosted a webinar where we discussed how some of today’s leading medical device manufacturers are utilizing peer reviews to meet industry standards, while designing the next generation of digital health solutions.

In this session, 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