RISK MANAGEMENTManage risk across the total product lifecycle

Seamlessly assess, prevent, and control risks to maintain compliance and build trust with patients and customers.

Build risk control into product design and development

Implement automatic ISO 14971 and FMEA compliance into your design controls
Improve the quality, safety, and effectiveness of your products
Ensure your quality and product teams are on the same page about risk strategy

Identify, prevent, and mitigate risks and vulnerabilities

Centralize risk identification, monitoring, prevention, and mitigation in a single source of truth
Define acceptable and unacceptable risks and apply these criteria across your organization
Employ an exportable risk matrix that details each hazard, situation, and harm, and calculates an initial risk score and mitigated risk score
Easily link to CAPA, internal audits, and customer complaints and feedback

Make stress-free audits possible

Demonstrate comprehensive risk control during external audits
Show traceability to related design controls and components
Stay compliant from premarket to postmarket

Explore other Enzyme eQMS modules


Simplify your supplier management process


Plan, conduct, and track your audits with ease


Meet your postmarket surveillance requirements efficiently and effectively
Wondering which QMS is right for you?
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