Medical technology companies have formidable goals: Moving fast, staying aligned, innovating without introducing risk, mitigating existing risk according to cost benefit analysis, causing no harm, and staying competitive and profitable. Despite cutting edge innovation and technological talent, many companies struggle. And Internet enabled, feature-rich tools bring infrastructure safety concerns—and evolving compliance regulations that reflect these new risks.
Working with medical technology customers, we’ve developed ways teams can use Jama to make product development easier, simpler and faster. You can: Show traceability from concept through every design step to production. Improve and maintain product quality. Uncomplicate FDA audits and achieve compliance.
Why Jama for Medical Technology Development?
- Trace requirements end-to-end
Link and decompose high-level requirements to more detailed system and sub-system requirements, include associated risks and hazards, and ensure proper validation and verification before release. Traceability in Jama increases efficiency, drives
alignment and mitigates product and company risk
- Manage risk analysis
View risks alongside related requirements and use calculated fields to calculate your risk priority number (RPN) within Jama. Identifying risks earlier in development can save teams from late stage design adjustments required to mitigate risks and ensures compliance is achieved.
- Design verification and validation
Seamlessly manage traceability to test cases used for verification and validation, and provide evidence to comply with government regulations and standards, like 21 CFR Part 820.
- See the impact of change quickly
Fine-grained impact analysis provides instant data insights. Use the analysis to make informed decisions as requirements evolve during long development cycles or due to shifts in technology.
- Conduct reviews and approvals
Increase stakeholder participation and incorporate feedback iteratively throughout a project. Within Jama, tie electronic signatures to specific reviews or baselines in compliance with 21 CFR Part 11.
- Maintain audit trails with reports
Customizable, real-time reporting and baselining allows you to track all changes to information within the system, including time-stamps and associated users. Data is easily exported from Jama if your current process dictates storage of documentation in a QMS.
Traceability: Your Product Development Map to Compliance
Traditionally, traceability has been a static snapshot of requirements data, something you must capture and provide for compliance purposes. In Jama, traceability is your ally to alert you towards gaps in coverage, ensure information is connected correctly and provide insights on the impact of a proposed change.
Jama Product Manager Robin Calhoun explains: “Jama’s Trace View makes data navigation interactive. You can fix what’s broken and ask questions such as, Is this covered or tested? Who wrote this? Why are we building this? When was this built? Jama’s traceability helps you focus on trends and patterns that concern you and not get bogged down in data detail. You can see the impact of a choice you are considering, so you have the necessary information to act.”
Use Jama to Reduce the Cost of Compliance
Modern medical device compliance requires exacting documentation along with organized and detailed communications. An example: A medical manufacturer for home products approached Jama after an FDA audit suspended its production rights. The FDA required the company to document its RM process, complete traceability and meet standards including ISO 14971, ISO 13485 and 21 CRF Part 11. The company partnered with Jama to redesign its processes and configure a solution to support them. Within one year, our customer had reduced risk and produced the necessary evidence to give the FDA confidence that its product was safe for consumers.
Customer Success Snapshot
For 30+ years, Fortune 500 companies have turned to Plexus engineers to design, develop and test Class II and III medical devices and life sciences products. Plexus is ISO 13485 and Quality System Regulation compliant with 13,000 employees, 23 facilities and 500 engineers worldwide. Regulatory approval requires Plexus to guarantee traceability and documentation. After considering a variety of solutions for collaborative, compliance- and audit-friendly RM, Plexus chose Jama.
“Our main performance measurement is repeat business from our customers. They don’t come back if we’re not meeting the schedule and project budget. And these are things that Jama helps us do. It makes us more efficient, leading to repeat business. Customers have stated that our mature process for managing requirements is a reason they select Plexus as a partner,” says Dave Strandberg, Director of Engineering Solutions.