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Medical device ERP that fits the way you work

Stop running your business on spreadsheets and workarounds. One system, set up around how you already work and changed whenever you need it, for one monthly fee.

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Free data migrationUnlimited usersCustom features included
Tidewell Medical
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Quotes
Orders
Invoices
Payments
Production
Work orders
Schedule
Work centers
Quality
Inspections
Nonconformances
CAPA
Buying
Purchase orders
Approved suppliers
Bills
Stock
Parts
Stock
Lots & serials
Counts
Contacts
Reports
Settings
Production manager
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Ask AI
Production / Work orders
WO-4127In progressHigh priorityDue Nov 24
Qty500
LotL-2714
CustomerVarden Surgical
OrderSO-2286
Customer POVO-40918
Operations6
Materials
Outside processing
Device history record
Files
Cost
3 of 6 operations done
OpWork centerSetup h
est / actual
Run h
est / actual
GoodScrapStatus
10
Swiss turn
Swiss lathe 2 · Ti-6Al-4V ELI bar
2.0 / 2.321.0 / 21.65064Done
20
Color anodize
Outside: Bayview Finishing · PO-1131
——5060Done
30
Clean and final inspect
Final inspection · 4 on hold, NCR-0318
0.3 / 0.37.7 / 7.55020Done
40
Cleanroom pack and label
ISO 7 cleanroom · UDI labels
0.5 / 0.68.4 / 4.12601In progress
50
Gamma sterilization
Outside: Corvane Sterilization · PO-1138
————Not started
60
Lot releaseQA sign-off
Sterilization cert · DHR review
—1.5 / ———Not started
Timeline
Add a note… type @ to mention
AllNotesChangesEmailsAI
Production manager · Email · Nov 10, 9:40 AM
PO-1138 sent to Corvane Sterilization for a gamma run
Operator · Change · Nov 10, 7:05 AM
Jada T. clocked on to op 40, cleanroom pack. Training on WI-221 rev C is current
Inspector · Change · Nov 9, 4:20 PM
Final inspection signed off: 502 passed, 4 held on NCR-0318 for MRB
Receiving · Change · Nov 7, 1:15 PM
506 back from Bayview Finishing, anodized gold, cert attached
One work order, end to end

Every work order in one place,
from quote to cost

Where this lives today
  • Quote spreadsheet
  • Whiteboard schedule
  • Paper travelers and DHRs
  • Emails to the sterilizer
  • Inspection binders
  • QuickBooks
Production / Work orders
WO-4071Closed (costed)Cost locked Sep 29
More ▾
Qty500
LotL-2651
CustomerVarden Surgical
OrderSO-2231
Customer POVO-40377
Operations6
Materials
Outside processing
Device history record
Files
Cost
Actual cost$7,425.00est $7,321.00
Margin33.7%est 34.6%
Cost per released part$14.85est $14.64
Scrap10 parts4 turning · 4 thread gauge (MRB) · 2 seal
Over estimate by $104.00, mostly from 0.9 extra hours on the Swiss lathe. The titanium bar came in $36.00 under.
EstimatedActualVariance $Labor hours est / actual
Materials
56 ft of Ti-6Al-4V ELI bar (ASTM F136), lot T-87650, at $18.00/ft
$1,044.00$1,008.00−$36.00—
Labor$4,787.00$4,919.00+$132.0041.4 / 42.4
10 Swiss turn · $140/h$3,220.00$3,346.00+$126.0023.0 / 23.9
30 Clean and final inspect · $90/h$720.00$711.00−$9.008.0 / 7.9
40 Cleanroom pack and label · $80/h$712.00$736.00+$24.008.9 / 9.2
60 DHR review and lot release · $90/h$135.00$126.00−$9.001.5 / 1.4
Outside processing
Op 20 color anodize · Bayview Finishing · Op 50 gamma · Corvane Sterilization
$1,030.00$1,030.00$0.00—
Other charges
Sterile pouches, UDI labels and IFUs
$460.00$468.00+$8.00—
Total$7,321.00$7,425.00+$104.00—
Revenue 500 × $22.40 = $11,200.00. Freight is passed through and not counted. Variance = actual − estimated.
Timeline
AllNotesChangesEmailsAI
Bookkeeper · Payment · Oct 27
INV-5106 paid
ACH $11,200.00
Production manager · Change · Sep 29
Work order closed, cost locked
$7,425 actual vs $7,321 est
Shipping · Change · Sep 28
500 shipped on SH-1418
With certificate of conformance and sterilization certificate
Quality · Change · Sep 25
Lot L-2651 released
Sterilization cert checked, DHR reviewed and signed
Receiving · Change · Sep 24
Back from Corvane Sterilization
500 units · sterilization lot G-4302
Operator · Change · Sep 17
Cleanroom pack and label complete
Counts and sign-offs added to the DHR
Receiving · Change · Sep 14
Back from Bayview Finishing
506 anodized gold, cert attached
Operator · Change · Sep 8
Bar lot T-87650 issued
Passed incoming inspection, cert attached
AI · Change · Sep 2
Created from order SO-2231
AI-drafted from PO VO-40377
AI · Email · Aug 12
Quote Q-5034 sent
AI-drafted from RFQ and drawing
AI features

AI does the office paperwork.
A person approves it.

AI drafts quotes from emailed RFQs, turns POs into orders at the current revision, checks supplier bills against what passed incoming inspection and follows up on payments. Nothing posts or sends until someone in the office approves it.

Quote drafting

Turns an emailed quote request into a ready quote, and prices repeat parts from what they cost last time.

RFQ: cortical screwsRenee Okafor, Varden Surgical
Can you quote 500 of CS-3524 rev D and 250 of CS-3540 rev B, sterile packed like last time? We need both by Nov 24.Thanks, Renee
Q-5102 · Varden SurgicalDue Nov 24Drafted by AI
PartQtyUnit price
CS-3524 rev D500$22.40
CS-3540 rev B
Repeat part, last cost $17.90
250$25.40

Order intake

Turns customer POs into orders matched to your parts and revisions.

SO-2286 · Varden SurgicalFrom customer PO VO-40918Drafted by AI
PartCS-3524 rev D
Qty500
Need byNov 24
The PO lists rev C, but ECO-0417 made rev D current. Confirm with the customer.

Bill capture and 3-way match

Checks supplier bills against the PO and what passed incoming inspection.

Bill B-6120Kestry TitaniumMatched by AI
POReceivedBill
Qty (ft)120112120
Amount$2,160—$2,160
Billed for 120 ft, but 112 ft passed incoming inspection. 8 ft were rejected on NCR-0322.

Collections

Reads replies to payment reminders, then pauses them or follows up.

INV-5188 · Ostrel Medical$8,640 · 14 days lateRead by AI
Nov 6 · Reminder sentYour invoice is 14 days past due.
Nov 7 · Customer replied"Paying Nov 20, once QA gets the CoC."
Read by AIPromise to pay Nov 20. CoC reply drafted for approval.

Ask your data

Ask about suppliers, scrap or margins. Every answer links to the records behind it.

Which suppliers fail QC?
Kestry TitaniumBar diameter4 NCRs
Bayview FinishingAnodize color3 NCRs
Halvern PackagingPouch seal1 NCR
Supplier-caused NCRs this year, with the most common cause
Built around how you make devices

Ask for it.
We'll build it.

Tell us what you need and we'll build it. Changes are included in your monthly fee.

"Can customer complaints link to the lots and DHRs they came from?"Built in 3 weeks
"Can we stop inspectors from using a gauge that's past its calibration date?"Built in 2 weeks
"Can ECOs route to engineering, quality and production for sign-off?"Built in 3 weeks
"Can each customer's quality agreement terms show on their orders?"Built in 1 week
Medical device ERP software

Built for the way medical device makers work

Q-5102 · CS-3524 rev D
Varden Surgical · RFQ-2207 · cortical screw, sterile packed
Won · SO-2286
Material and routingSetupRun / pcAt 500
Ti-6Al-4V ELI bar, ASTM F136—58 ft at $18.00$2.09
10 Swiss turn · Swiss lathe 22.0 h2.5 min$6.44
20, 50 Anodize and gamma, outside—$2.06$2.06
30 Clean and final inspect0.3 h0.9 min$1.44
40 Cleanroom pack, UDI label0.5 h1.0 min$2.34
60 DHR review and release1.5 h—$0.27
Cost per part$14.64
250 pcs$26.9042.0% margin · 25 days500 pcs$22.4034.6% margin · 25 days1,000 pcs$19.6027.8% margin · 35 days

Medical device quoting with quantity breaks

Price every quantity from real material, machine and cleanroom time, anodizing and sterilization. Setup is spread across the lot, so bigger lots cost less per part.

  • Setup and run per work center, from Swiss lathe to cleanroom
  • Repeat parts priced from their last lot
  • Winning a quote creates the part, revision and routing
Production schedule
All work centers · due-date order
Today, Tue 10
Work centerMon 9Tue 10Wed 11Thu 12Fri 13Mon 16Tue 17Wed 18Thu 19Fri 20
Swiss lathe 1Swiss turnWO-4133 · 10CS-3540 · VardenWO-4138 · 10CS-3524 · Varden
Swiss lathe 2Swiss turnWO-4126 · 10On hold · NCR-0324WO-4135 · 10DG-0414 · Ostrel
Clean and inspectUltrasonic · QCWO-4119 · 30Late · due Nov 9WO-4130 · 30DG-0412WO-4131 · 30CS-3530 · Varden
CleanroomISO 7 packWO-4127 · 40CS-3524 · 260 of 502WO-4130 · 40DG-0412 · Ostrel
OutsideAnodize · gammaWO-4122 · 50Gamma · CorvaneWO-4127 · 50Gamma · Corvane · PO-1138
QA releaseDHR reviewWO-4122 · 60DG-0410WO-4127 · 60Lot L-2714
RunningLateQuality holdScheduledAt outside processorToday

The production schedule

See every operation queued and running at every work center, in due-date order. Late work orders and lots on hold are flagged.

  • A column per work center, from Swiss lathe to cleanroom
  • Lots on quality hold show their NCR
  • Lots out for anodize or sterilization show on the schedule
CleanroomISO 7 · pack line 1Jada T.JT
Trained on WI-221 rev C · in at 7:05 AMWO-4127 · Op 40CS-3524 rev D · Varden Surgical · lot L-2714
Packed and labeled260 / 502Seal checks3 / 3
UDI labels printed and scannedLot L-2714 · 260 issued to the DHR
Work instructionWI-221 rev CPouch, seal, label and box in tens
Good parts this session
−140+
Reject: sealReject: labelPouch damageNext: op 50, gamma at Corvane Sterilization on PO-1138Log counts to the DHR

The shop-floor tablet

Operators sign in with a PIN, and only operators trained on the current work instruction can start the op. Counts and rejects go straight into the device history record.

  • Blocks operators not trained on the current work instruction
  • Scan the traveler QR to start an op
  • Counts, rejects and lots go straight to the DHR
WO-4071 · Cost
CS-3524 rev D · Varden Surgical · 500 released · cost locked Sep 29
Closed
Actual cost$7,425$104 over estimateMargin33.7%on $11,200 revenuePer released part$14.85est $14.64 · 10 scrapped
CostEstimatedActualVariance
Labor41.4 h est · 42.4 h actual, Swiss lathe +0.9 h$4,787$4,919+$132
MaterialsTi bar lot T-87650 · 56 ft of 58 est$1,044$1,008−$36
Outside processingAnodize, Bayview · gamma, Corvane$1,030$1,030$0
Pouches, UDI labels, IFUs$460$468+$8
Total$7,321$7,425+$104

Work order costing

Every work order shows estimated vs actual for material, labor, cleanroom time and outside anodizing and sterilization, so you can see which parts make money.

  • Quoted vs actual hours per op
  • Scrap and rejects costed
  • Cost per released part
Included

Everything a medical device manufacturer needs, all included

One system, no add-on modules to buy.

Sell

  • Quoting from operations, cleanroom time, anodizing and sterilization
  • Orders with customer part numbers and revisions
  • Shipping with certificates of conformance
  • Invoices and payments (card and ACH)
  • Customer portal

Make

  • Work orders and routings
  • Device history record for every lot
  • Shop floor (tablet and phone)
  • Production schedule
  • Work order costing

Quality

  • Incoming, in-process and final inspection with sign-offs
  • Nonconformances and quarantine holds
  • CAPA with root cause and follow-up
  • Approved supplier list
  • Training records, checked before operators sign

Buy and stock

  • Purchasing and outside processing (anodizing, passivation, sterilization)
  • Receiving with incoming inspection
  • Lots, serials and material certs
  • Stock and barcode scanning, including UDI labels
  • Material planning

Money and data

  • QuickBooks and Xero sync
  • Reports and Ask your data
Pricing

How pricing works

How pricing works

One monthly fee plus a one-time setup, quoted after we've seen how you work.

  • Unlimited users, including the cleanroom and quality team
  • Hosting, data migration, AI features and support included
  • Changes included, not billed as change orders
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Who builds it

Made by Airdev

Airdev has designed, built and supported custom software for over a decade. The same team builds and supports your ERP.

Visit airdev.co
1,000+products built
10M+users
$1B+in transactions
Get started

Get a demo built for your medical device company

Tell us how you build, inspect and release devices.After the call, we'll build a demo set up around it.

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