From design to market.
Quality and control built in.
Stop running a regulated company on spreadsheets, a separate QMS and separate accounting. Valydity connects development, production, quality and finance - so your teams work from shared records, with approvals, traceability and an audit trail built in.
One device. Connected records.
Device controller · CTRL-100
Development & quality
An approved design becomes the production specification.
DMR · CTRL-100 · revision 1
ReleasedDesign outputs, the BOM and controlled documents stay linked to the device.
Controls at this step
- Design reviews and required deliverables complete
- Approved BOM and active production flow
- Design transfer prerequisites checked
People make the decisions. Valydity checks the prerequisites and records the actions.
Linked activity
Design review passed; approved outputs linked to the device master record.
One illustrative device workflow · sample records · select a stage to explore
Capabilities: Lot genealogy, Incoming inspection, Quarantine & release, NCR, CAPA, Complaints, Document control, DMR, UDI, Audit trail, Role-based access, Four-eyes close, Israeli VAT, Uniform Format 1.31, Allocation numbers, Gapless numbering, Balanced journals, Period lock.
Connected by design
Less duplicated work.
More control.
Before
Re-entering information across separate tools.
With Valydity
One connected operational picture.
Bring development, purchasing, production, quality and finance together around shared information.
Before
Chasing approvals and missing evidence.
With Valydity
Clear ownership. Controlled handoffs.
Keep required reviews, approvals and supporting records with the work they govern.
Before
Piecing together the history before an audit.
With Valydity
Traceability built into daily work.
Follow materials, device history and quality events through linked records and an audit trail.
Platform
Built for medical device companies.
Connected across the business.
Quality & regulatory
Quality built into everyday work.
Controlled documents, training, inspections, NCR/CAPA, audits and accountable approvals — connected to the operational records they govern.
Applicable prerequisites are checked before the finished lot is released.
DOC-0207
Production SOP · revision 4
Training
Effective revision read and confirmed
AUD-0012
Internal audit · finding assigned
CAPA-0031
Supplier issue · effectiveness review
Illustrative records and release-control example.
Development & design controls
Carry approved designs into production.
Connect requirements, risk, design reviews, controlled specifications and design transfer.
Purchasing & suppliers
Connect suppliers, orders and receipts.
Keep supplier qualification and incoming inspection alongside purchasing.
Production & traceability
Know how each device was built.
Approved BOMs, production flows, work orders, material genealogy and device history.
Sales & finance
From customer orders to financial control.
Connect sales, shipments, invoicing, payments and financial reporting in one operational flow.
Post-market
Turn field feedback into action.
Connect complaints, post-market surveillance and corrective actions to the products and processes they affect.
AI assistance, with accountability
Less routine work.
Your team stays in control.
Ask about your operations. Request reports on production, quality, inventory or finance in plain language. Results are calculated from your company’s records.
Import data with less manual mapping. AI uses column names and sample values to suggest mappings, explain suggested matches and flag uncertainty for review.
Extract information instead of retyping it. Extract information from supplier invoices for checking and processing.
Get guidance where you work. Explain setup tasks and answer questions using company records or the product manual.
AI assists with information and preparation. Permissions, configured rules and required approvals govern what happens next.
Ask about your operations
Interactive example · sample data only
“Show open nonconformances by severity.”
Open nonconformances by severity
Status: Open · 5 sample records
Source: Nonconformances
| Record | Severity |
|---|---|
| NCR-0114 | Major |
| NCR-0118 | Minor |
| NCR-0121 | Major |
| NCR-0125 | Minor |
| NCR-0128 | Major |
AI interprets the request. Valydity calculates the report from company records and shows its source.
Interactive example · sample data only
Use sample values to interpret unfamiliar column names. Resolve the ambiguous Owner column before approving.
Ref #
S-1042 · S-1186
Repeated supplier references suggest the supplier code.
Account / payee
Helix Components Ltd. · Cobalt Packaging GmbH
The sample values are company names, suggesting the supplier name.
AP desk
Email addresses in the sample values suggest a supplier contact email.
Owner
Maya Chen · David Levy
These could be your internal buyers or supplier contacts. Confirm what the names mean before importing.
Choose a field for each highlighted column, or select Do not import.
Auditable records
Changes, decisions and signatures recorded with their history.
Controlled access
Permissions aligned with each person's responsibilities.
Data isolation
Your company's information remains separate from other organizations.
Controlled approvals
Required reviews and sign-offs performed by authorized personnel.
Straight answers.
Who is Valydity for?
Medical device companies that want to connect development, purchasing, production, quality, post-market activities and finance. Valydity supports teams moving toward first production as well as growing manufacturers.
Is Valydity an ERP or a QMS?
Both. Valydity brings operational and quality-management workflows into one platform, connecting business transactions with controlled documents, approvals, traceability and supporting records.
Can we start before commercial production?
Yes. Setup requirements adapt to your company’s stage and device characteristics. You can begin with design and quality processes, then complete the production, inventory and financial setup required as your operations grow.
How does AI assist the team?
AI helps map spreadsheet imports, extract supplier-invoice information, explain setup tasks and build reports from company records. Permissions, configured rules and required approvals govern processing. For example, eligible vendor bills can post under configured matching rules, but require human review before payment; quality sign-offs remain with authorized people.
What if AI is unavailable?
Core operational workflows can continue without an AI provider. Some assisted tasks use rule-based suggestions; others need manual entry. For example, a scanned invoice that cannot be read automatically can be completed by a person.
How does Valydity support regulated operations?
Controlled documents, training, traceability, electronic signatures and review workflows help teams manage their quality processes and evidence. Valydity supports your quality system; using it does not by itself establish regulatory compliance or certification.
Which countries does Valydity support?
Valydity includes country-specific finance features for Israel, Austria and Germany, alongside shared EU capabilities. Coverage varies by country and workflow. During a demo, we can review the invoicing, tax and banking features your company needs.
What does it cost?
Talk to us about your team, company stage and the workflows you need. We can discuss a suitable plan during your demo.
Valydity supports controlled processes and recordkeeping. Your organization remains responsible for its quality system, validation and regulatory obligations.
Your workflows. One connected platform.
See how Valydity
connects your operations.
Walk through your own processes with us and see how Valydity brings development, production, quality and finance together.