Solutions for Medical Device & Diagnostics Teams

Compliance in 2020 and beyond

2020 is expected to bring increased scrutiny and tighter regulations to medical device and diagnostics companies across the globe. The looming EU MDR deadline in May and subsequent IVDR changes in 2022 continue to put pressure on European and US markets. That, coupled with a call for tighter US regulations, as evidenced by press that continues to accumulate, will lead to significant industry changes in 2020 and beyond.

It’s a lot of pressure, for individuals, for teams, for companies and investors, to deliver safe, compliant and quality products and solutions. And as a medical, marketing, legal or regulatory reviewer at a device or diagnostics company, your daily actions are a crucial piece of that larger story.

Speed and compliance, together at last

The pressures don’t stop with compliance. Getting promotional and medical information materials approved quickly can also be a challenge for MLR and MRC teams, especially if you’re repurposing other compliant workflow solutions already in use.

We know the inefficiencies that come along with shoehorning your work into a system made for other processes:

  • collaboration is almost non-existent,
  • the software does not support all of your robust marketing files, and
  • it takes 3+ months to get materials approved.

Worse yet, you may not be using a system at all. Your team is buried under emails, or stacks of file folders and paper. Questions about prioritization are constant.

Luckily, you don’t have to sacrifice speed for compliance. With the Pepper Flow® product suite, you can collaborate with colleagues, prioritize your work, and spend less time in review meetings— it’s the beauty of a regulated content management solution designed with your specific needs in mind.

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Pepper Flow® Quality system PLM system Paper/Email
GENERAL FEATURES
Parallel and sequential review
Permissions-based security
Version control
Audit support
21 CFR Part 11 compliant e-signature
QMS-specific features (e.g. CAPA, customer complaint tracking, etc.)
PLM-specific features (e.g. manufacturing process planning, CAD files, etc.)
PROMOTIONAL REVIEW FEATURES
Comprehensive file type support (PDFs, images, videos, etc.)
Browser-based annotations
Claim linkages
Operational metrics reporting
Workload visibility (job status and due date management)
Next-generation features (web and interactive content review, machine learning)
IMPLEMENTATION & ONGOING OPERATIONS
Out-of-box or custom configurations based on business needs
Validated, quarterly releases
Unlimited configuration changes (no cost)
Unlimited training (no cost)
User Support (24x7, email, online chat) Added costs
The extras:
  • Turnkey implementation: Whether you’re just starting out or require a complex workflow configuration, we have you covered with implementations right-sized for your business, including out-of-the-box, custom, and enterprise options
  • Transparent, affordable pricing: Tight budgets shouldn’t be the reason you’re sacrificing speed or compliance. With Pepper Flow, the price reflected in your proposal represents your total investment for the duration of your contract. No hidden fees for training, ongoing support, or administrator certifications here!

Our products

Built exclusively for the MLR and MRC processes, our Pepper Flow products are hyper-focused on enabling speed-to-market and ensuring compliance for Medical Device and Diagnostics teams.

All of the features you need, none of the ones you don’t.

Route, review, and approve promotional materials

Route, review, and approve medical and scientific communications

Review and annotate directly on web content with the industry’s only native review solution

Distribute MLR & MRC-approved materials to sales reps and MSLs

Medical Device & Diagnostics Success Stories

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Press Release

Exact Sciences Selects Vodori’s Pepper Flow to Support Commercialization of Cologuard

Read On

“We really value our partnership with Vodori. You’ve taken our MLR process to a new level.”

– Associate Project Manager, Commercial Enablement, Molecular Diagnostics Company
View Testimonials
collaboration-for-a-stronger-result-case-study

Case Study

Pepper Flow® Commercial Reduces Time Spent Managing the Promotional Review Process by 50%

See How

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