Everything we do is held to the highest standards in accordance with our ISO 9001:2015 compliant quality management system.
Has your company ...
- Deployed a field action due to a failed component?
- Initiated a recall due to a supplier issue?
- Launched a corrective action due to medical device mislabeling?
Novasyte has more than a decade of experience partnering with many of the largest device, diagnostic and drug manufacturers, helping them respond to all levels of regulated field actions including FDA-mandated recalls. Learn more about our S.M.A.R.T. technology by watching this quick video.
Our cloud-based S.M.A.R.T. Response Program is an integrated, software and service-based solution that provides comprehensive management and real-time activity tracking, allowing our clients to quickly and accurately execute regulated field actions without overburdening their internal teams.
Results have included achieving FDA compliance in an average of 10 weeks and proving effectiveness with clean and accurate data to support their request for closure - resulting in the FDA approving termination in as quickly as 5 days.
Our dedicated S.M.A.R.T. team manages every step of your field action and delivers reporting in real-time, ensuring traceability, accuracy and speed.
Key Benefits:
- Flexibility - Closed-loop management support with the flexibility to scale up and down as needed
- Bandwidth - Maximize your team's bandwidth while we serve as an extension of your team
- Real-time Data and Activity Tracking - Receive real-time, data analytics to maximize program success
- Strategic Implementation - Customize the strategic implementation plan to meet your program goals
- On-Site Remediation and Retrievals - Tracked on a per-unit basis and handled by our highly-skilled technicians
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Novasyte builds, deploys and manages all field teams with quality management standards that are ISO 9001:2015 certified - allowing us to deliver consistent results and continually improve satisfaction for 
you and your customers.
Once a customized plan is developed, our highly-skilled S.M.A.R.T. response experts are quickly mobilized to manage the action with speed and accuracy.
We measure and track the progress and associated spend in our proprietary Novasyte LYNC platform. This provides real-time visibility into every activity tracked and every dollar spent on Novasyte services so you can stay informed and evaluate where and when support is needed.
Our proprietary, Novasyte LYNC platform tracks every consignee activity, including:
- KPI measurement (e.g. expense-to-service ratios)
Affected product tracking and product return per unique serial number- Field-based activities and spend by account, region, product, supervisor, task and unit
- Recall notification and delivery status
- Consignee acknowledgment status
- First pass yield tracking
- Recall status reports
Contact us for a personalized demo from our team of recall experts today!
