Improve Patient Safety & Meet Global Regulations
Regulatory agencies and notified bodies require medical device manufacturers to digitize and improve delivery of Instruction for Use (IFU).
We are "SINGLE VENDOR" for your eIFU needs
- MDR, FDA and other regulations Compliant
- Role & Permission Driven (for manufacturer login)
- End consumers/customers access website (without login) and search, view, save, and print, your published IFUs.
- Multi-language, Multi-versions linked by Products
- Enterprise version option with workflows, connect to your PLM & EDMS, custom branding and other premium features
- 21 CFR Part 11, GAMP compliant
- Data Security, GDPR& High Availability (hosted in ISO 27001 certified Data center in Frankfurt, Germany)
- Call center service 24x7
- Take “print” requests and ship hard copies (or optionally, coordinate with manufacturer fulfillment teams)
- Maintain TAT for 7 days (as per Regulation)
- Provided audits trail reports for action by your users to help maintain traceability, and compliance with regulatory requirements.
- Additional professional services like SOPs, Risk analysis
How can you get started?
|
Free
$0
|
Medium
$139 per month billed annually
|
Enterprise
Call/Email Sales
|
|---|---|---|
| Users – 1 | Users – 2 (Admin & Author) | Custom |
| Products – UP TO 2 | Products – UP TO 10 | Unlimited |
| Documents – UP TO 20 | Documents – UP TO 100 | Unlimited |
| Storage – 1GB | Storage – 5GB | Custom |
| Support – Email only | Support – Email & 8×5 Phone service desk | Support – Email & 24×7 Phone service desk |
| Data Center – Germany | Data Center – Germany | Data Center – Germany or USA (customer preference) |
| Validated, GDPR compliant | Validated, GDPR compliant | Validated, GDPR compliant |
| Multi-lingual and multi-version | Multi-lingual and multi-version | Multi-lingual and multi-version |
| Self-service | Self-service & 1 webex training | Custom Onboarding & Adoption guidance |
| Print order fulfilment at extra cost | Print order fulfilment at extra cost | Print order fulfilment included |
| Custom Domain name | ||
| Wokflows for Approvals and Publishing | ||
| Custom Integrations to other Software | ||
| Online tickets link to customer internal Queue or portal or team | ||
| Service Level Agreement (SLA) management | ||
| Out-of-the-box reporting and analytics | ||
Frequently Asked Questions (FAQs)
We offer this to small manufacturers to help them reduce compliance overheads. We strongly believe most of these smaller firms grow and will upgrade to our paid packages in future. There’s no time duration for FREE version and manufacturers can have this however long they wish to.
We accept Credit card as well as SWIFT/RTGS/ACH payments. We can also invoice you as an option.
Please check the pricing above.
Yes, you can upgrade plans at any time
Yes, you can upgrade plans at any time
Yes, all subscription fees are renewed automatically on a recurring basis until user cancels their subscription.
Please email support at wecanhelp@ddismart.com before your renewal date. Please refer to our cancellation policy on pricing page under Pricing & Plans.
Yes. EU, FDA. EU MDR, eIFU are some of them.
Our team of expert regulatory professionals will regularly update the country specific regulatory requirements.
You can maintain multiple versions and ViSU has multi-country & multi-language features included.
Data is stored in our “Private cloud” hosted in ISO 27001 certified Data center in Frankfurt, Germany (optionally we can give NJ, USA as another option)
Yes. ViSU is validated as per 21 CFR part 11 and GAMP for electronic records and electronic signatures to ensure accuracy, reliability and consistent intended performance.
All sensitive data information are encrypted end-to-end including data at-rest and in-transit using User management and access control/restriction are followed to ensure only the right people have access to data at the right time and also personal information is accessible only to those authorized who we believe reasonably need to come into contact with that information to provide products or services.
Yes. Procedural safeguards, security measures and Privacy Policy are in compliance with GDPR to protect and safeguard GDPR principles
We maintain 24x7 Service desk and follow ISO 20000 policies. Service Level Agreement (SLA) will be provided to manufacturer upfront and corresponding reports periodically
Once user requests for print IFU, within which timelines a printed version of the IFU will be delivered to them in maximum of 7 calendar days. We can use our courier/shipping or bill to manufacturer preferred vendor or forward these requests to manufacturer for their internal fulfillment.
The First Step
Let's talk about how DDi can help you