Medical devices: Lean software for medical device manufacturing, beside your QMS
Medical device manufacturing runs to ISO 13485 and FDA's QMSR, so a missed step, an untrained operator or an open NCR matters. LeanSuite is the daily-management and improvement layer next to your QMS. It runs work instructions, operator skills, NCR follow-up, audits and kaizen. It is not a validated quality record system.
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The process
How medical device manufacturing works, stage by stage
Most single-use and assembled devices pass through the same five stages, from component to released lot. Each one loses time or quality in its own way.
Component molding and machining
Plastic parts are molded and metal parts machined, often in-house, to tight tolerances.
Where time and quality are lost
- Short shots, flash and dimensional scrap, long mold changes and first-article checks that stop the press.
Cleanroom assembly
Operators assemble, bond and test the device by hand or on semi-automatic stations in a controlled environment.
Where time and quality are lost
- Missed or swapped parts, bonding defects, unbalanced cells and gowning time each time someone enters or leaves.
Packaging and sealing
Devices are placed in their sterile barrier packaging, sealed, labeled and cartoned.
Where time and quality are lost
- Seal defects, label mix-ups between lots and changeovers between pack sizes.
Sterilization
Lots are sterilized, often by an outside contractor using ethylene oxide or radiation.
Where time and quality are lost
- Lots waiting for a sterilization slot and for results, and inventory tied up while they wait.
Final inspection and release
Lots are inspected, their records reviewed and the lot released for shipping.
Where time and quality are lost
- Records sent back for corrections, open NCRs holding a lot, and inspection queues at the end of the month.
The problem
What slows medical device plants down
Medical device plants build to tight specifications under a quality system, often by hand in a cleanroom. Here is where that slows them down.
NCR and CAPA backlog
Nonconforming product waits for disposition, and CAPAs stay open for months while the same defects return. Which NCR and CAPA records your QMS requires, and where they live, is for your quality team to decide; the delay is often in the daily follow-up.
Assembly errors and missed steps
Manual assembly of small parts, often under magnification, has dozens of steps where a missed or swapped part is easy. Paper travelers and binder instructions fall behind engineering changes.
Qualified operators on every station
Each operator must be trained and qualified on a procedure before running it, and requalified when it changes. When someone is out, supervisors need a qualified replacement now, and auditors ask who was qualified on a past date.
Changeovers and line clearance
Lines that build several models or sizes need a clearance between lots, so labels, components and travelers from the last lot never reach the next one. A signed sheet does not show which stations were actually checked.
Scrap in validated processes
Molding, bonding and sealing are validated, so a process change needs change control and often revalidation. Plants live with scrap because the fix looks slow, and nobody has put a cost on it.
Unbalanced manual assembly cells
Cleanroom cells are staffed by hand, and work drifts out of balance as volumes and models change. One overloaded station sets the pace while others wait.
How LeanSuite helps
How LeanSuite helps medical device plants
Each problem maps to a LeanSuite module you can start with on its own, then connect to the rest. None of them replaces your QMS.
NCR and CAPA backlog
In LeanSuite: Each non-conformance is captured with photos and routed to quality and engineering. Containment tasks, such as quarantining a batch, are assigned and time-stamped before root cause analysis starts. Systemic issues run through 8D or DMAIC in Kaizen & Projects, and the fix goes to every affected operator as a One-Point Lesson before the NCR closes.
Assembly errors and missed steps
In LeanSuite: Film the job once and LeanSuite drafts the work instruction with numbered steps, photos, tools, PPE and warnings from the video. Engineers can edit every step before it is published, and drafts can be routed to engineering, EHS and quality for sign-off.
Qualified operators on every station
In LeanSuite: Competency Management keeps a live skills matrix whose levels update as people complete training and on-the-job sign-offs. The Job Cover Matrix filters qualified, available people by shift, department or proficiency, and CILR tasks can be linked to the matrix so only certified operators sign off.
Changeovers and line clearance
In LeanSuite: Audit management in LeanSuite lets you build, schedule and run any shop floor audit or inspection, from layered process audits to gemba walks, and turn every finding into a tracked action. Every record is time-stamped, failed items become corrective actions tracked to verified closure, and completed checklists export to PDF or CSV for the auditor.
Scrap in validated processes
In LeanSuite: Issue Management logs each defect where it is found. The Quality Matrix puts a cost on it across product lines and processes, and Kaizen & Projects runs the root-cause project and verifies the fix.
Unbalanced manual assembly cells
In LeanSuite: Upload a video of the line and Vision AI produces a Yamazumi chart, a takt comparison and rebalancing recommendations. It balances mixed-model lines by weighting elements by product mix. Vision AI is priced separately from the facility plan.
Standards
Standards and regulations medical device plants work to
These are the standards and rules medical device plants most often work to. They are named here so you know which ones your own quality system covers; LeanSuite does not make a plant compliant with any of them.
- ISO 13485The quality management system standard for medical devices, used for certification and by regulators around the world.
- FDA QMSR (21 CFR 820)FDA's Quality Management System Regulation. Since February 2, 2026 it incorporates ISO 13485:2016 by reference, with some FDA-specific requirements kept.
- ISO 14971Risk management for medical devices, across design, production and use.
- EU MDR (Regulation (EU) 2017/745)The EU rules for placing medical devices on the market, including the quality system and post-market surveillance.
- 21 CFR Part 11FDA's rule for electronic records and electronic signatures used in place of paper records.
- ISO 14644 and ISO 11607Cleanroom classification and monitoring (ISO 14644) and packaging for terminally sterilized devices (ISO 11607).
LeanSuite runs beside your QMS, not as one
LeanSuite is the daily-management and improvement layer of a device plant: work instructions, operator skills, issue and NCR follow-up, audits, kaizen and time studies. It is not a validated quality record system and not a quality management system. Device history and lot records, complaint files, design and risk files, and the CAPA and nonconformity records your procedures define belong in your validated eQMS or MES. Any electronic record that must meet 21 CFR Part 11 belongs there too. ISO 13485 needs software used in your quality system to be validated for its intended use. If a LeanSuite record counts as a quality record, your team needs to validate it for that use. We do not claim a validation for you. If one platform must give you Part 11 e-signatures, batch records and validation support, compare LeanSuite with Tulip.
KPIs
The KPIs to track, and how to calculate them
The numbers medical device plants track most, and how each is worked out. Track yield per step, not only at the end of the line.
First-pass yield
Formula: Units passing a step first time, with no rework ÷ units entering the step × 100
Multiply the steps' yields for rolled throughput yield, which shows the whole line.
NCRs per 1,000 units
Formula: NCRs raised ÷ units made × 1,000
Split by source: incoming, in-process, final inspection, customer.
CAPA cycle time and on-time closure
Formula: Average days from CAPA opened to closed; CAPAs closed by due date ÷ CAPAs due × 100
Count a CAPA as closed only after its effectiveness check.
Complaints per million units
Formula: Complaints received ÷ units shipped × 1,000,000
Trend by failure mode, and link each to its investigation.
Scrap cost
Formula: Units scrapped × cost per unit at the step where they were scrapped, per month
A unit scrapped after sterilization costs far more than one scrapped at molding.
OEE on molding and packaging
Formula: Availability × Performance × Quality
Most useful on the automated steps; manual cells are better measured against takt.
Qualified coverage
Formula: Stations with at least two qualified operators on the shift ÷ stations staffed × 100
Include requalification after a procedure change.
Illustrative numbers for one week on a single-use device line. 2,400 units started at molding: 2,352 passed molding first time, 2,328 passed assembly and 2,305 passed final inspection.
Worked example: rolled throughput yield on a device line
Example numbersMolding yield: 2,352 ÷ 2,400
98.0%
Assembly yield: 2,328 ÷ 2,352
99.0%
Final inspection yield: 2,305 ÷ 2,328
99.0%
Rolled throughput yield: 98.0% × 99.0% × 99.0%
96.0%
Units lost or reworked: 2,400 − 2,305
95 units
Per 1,000 units started: 95 ÷ 2,400 × 1,000
39.6
What each KPI tells you and how to measure it on the floor is in the lean playbook for medical device plants.
Answers
Common medical devices questions, answered
What is ISO 13485?
ISO 13485 is the international quality management system standard for medical device makers and their suppliers. It covers management responsibility, resources and training, design and development, purchasing, production and service, traceability, measurement, nonconforming product, and corrective and preventive action. Plants are certified to it by a registrar, and FDA's QMSR now builds on it. LeanSuite does not certify you to ISO 13485; it runs daily routines that your own procedures may call for.
What is the FDA QMSR (21 CFR 820)?
The Quality Management System Regulation is FDA's rule for medical device quality systems. It replaced the older Quality System Regulation and took effect on February 2, 2026. It incorporates ISO 13485:2016 by reference, so one quality system can serve both, and it keeps some FDA-specific requirements, such as labeling and packaging controls. FDA inspects device makers against it.
What is a device history record?
FDA's former Quality System Regulation called it the device history record: the record for each lot or unit that shows it was made as specified. It holds dates, quantities made and released, acceptance records, the labels used and the device identifier. Under the QMSR, FDA uses ISO 13485's terms instead, but plants still keep a record for each device or batch with the same content. That record belongs in your QMS or MES.
How should CAPA work in a medical device plant?
ISO 13485 keeps corrective action in clause 8.5.2 and preventive action in clause 8.5.3. A CAPA starts from a nonconformity, a complaint, an audit finding or a trend. It records the problem, the investigation and root cause, the actions, and a check that the actions worked before it closes. Keep CAPA for systemic problems and fix one-off issues with a correction, or the CAPA list grows faster than anyone can close it.
What is ISO 14971, and how does it reach the production floor?
ISO 14971 is the risk management standard for medical devices. It asks makers to identify hazards, estimate and control the risks, and review them across the device's life. On the floor it shows up as a process FMEA for each line, controls such as error-proofing on the steps with the highest risk, and production data that feeds back into the risk file.
Customers
Companies that use LeanSuite
Whirlpool case study
How Whirlpool tackled project visibility and continuous improvement across 14 manufacturing plants with LeanSuite.
Its Global Kaizen Power Pitch saw 150 Kaizen presented, $14.8M in hard savings and $17.6M in soft savings.
14
Manufacturing plants
150
Kaizen presented at the Global Kaizen Power Pitch
$14.8M
Hard savings
$17.6M
Soft savings
What getting started looks like
Under a week
Until your first module is live; our team does the setup
$3,000
90-day pilot per facility
One flat price per facility
Unlimited users, so adding people does not change the price
99.5%
Monthly uptime commitment in the service agreement
SOC 2 Type 1 audited, hosted on secure cloud infrastructure, with single sign-on through Microsoft Entra ID or Okta and employee-ID sign-in for operators without email. Details on the security page.
Want to try it on one line first? See how the 90-day pilot works.
Free resources
Guides and templates
Free guides, templates and buyer's guides for medical device plants, with no sign-up to read them.
Free tools
Related free calculators
Work out the numbers behind these problems. Each calculator shows its formula and a worked example, with no sign-up.
First pass yield (FPY) calculator
First pass yield at each step and rolled throughput yield (RTY) across the whole process.
Open calculatorCost of poor quality (COPQ) calculator
Total COPQ and cost of quality, and each as a share of revenue, from the four quality cost categories.
Open calculatorLine balancing calculator
Line efficiency, balance delay and the minimum number of stations from station times and takt.
Open calculatorProcess capability (Cp, Cpk) calculator
Cp and Cpk against your specification limits, plus Pp and Ppk from pasted measurements, with a distribution chart.
Open calculator
FAQ
Questions from medical device plants
No. Your device history and lot records, complaint files, design and risk files and the CAPA records your procedures define belong in your eQMS or MES. LeanSuite runs the daily routines around them: work instructions, operator skills, NCR follow-up, audits and kaizen.
It applies to any software you use in your quality system. If a LeanSuite record counts as a quality record in your procedures, your team needs to validate LeanSuite for that use; we do not claim a validation for you. You can also keep LeanSuite for improvement and daily management only, outside the quality record.
Yes. Instructions are drafted from a video of the job with numbered steps and photos, edited by engineers before they are published, and read on a tablet at the station. Each change is versioned and routed for sign-off.
LeanSuite is one flat price per facility with unlimited users, so every operator on every shift can use it without adding seats. There is no published annual price; you can request a quote on the pricing page. Operators sign in with an employee ID, no company email needed.
The first module is live in under a week, and LeanSuite's team does the setup. A 90-day pilot costs $3,000 per facility.
See LeanSuite on your assembly floor
Bring the routine you want to fix first. We will show you how LeanSuite handles it and what a 90-day pilot would cover.